Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are seeking a highly experienced and strategic Senior Database Administrator (DBA) and enterprise application architect to join our IT team. The ideal candidate will bring over fifteen years of hands-on expertise in Oracle Database Administration, MS SQL Server, and multi-platform enterprise application  environments such as Oracle, SAP, JDEdwards, on different operating systems including Linux/Unix and Windows. This role also requires deep technical knowledge of application architecture, datacenter infrastructure, including networking, virtualization, and enterprise storage systems. The Senior DBA and architect will play a key role in architecting and designing database and infrastructure solutions, providing day-to-day operational support, and leading technical delivery of complex projects to support our enterprise applications.

What you'll be doing:

• Architect and design scalable, secure, and high-performance database solutions across Oracle and MS SQL Server platforms.
• Lead the architecture and integration of database systems with datacenter technologies including networking, virtualization, and storage.
• Provide day-to-day support for production, development, and test database environments, ensuring optimal performance and uptime.
• Collaborate with infrastructure, application, and security teams to align database and datacenter strategies with business goals.
• Lead the technical delivery of database and infrastructure projects, including upgrades, migrations, and consolidations.
• Develop and enforce database standards, best practices, and security policies.
• Perform capacity planning, performance tuning, and disaster recovery planning.
• Troubleshoot and resolve complex issues across database, OS, network, and storage layers.
• Ensure core enterprise applications are performing at optimal speeds and are fully backed up and redundant.
• Mentor junior DBAs and technology managers to serve as a subject matter expert across all IT teams.

Technical Skills & Expertise:

Enterprise Applciations:

• JDEdwards
• Oracle Applications
• D365
• SAP
• PTC
• Siebel
• Salesforce
• Workday
• Other HRIS Platforms

Database Platforms:

• Oracle: 10g, 11g, 12c, 19c
• MS SQL Server: 2008, 2012, 2016, 2019, 2022
• Postgres
• NoSQL Databases
• ODBC
• Reporting Replicas
• Datawarehousing Techniques
• Snowflake
• PL/SQL, T-SQL, SQL performance tuning

Operating Systems:

• Unix/Linux: Solaris 5, AIX, RHEL, CentOS
• Windows Server: 2003, 2008, 2012, 2016, 2019, 2022

Datacenter Technologies:

• Networking: TCP/IP, DNS, DHCP, VLANs, firewalls, load balancers
• Virtualization: VMware vSphere/ESXi, Microsoft Hyper-V, Oracle VM
• Storage: SAN/NAS, RAID, Fibre Channel, iSCSI, NetApp, EMC, Dell EqualLogic

Cloud Technologies:

• AWS
• Azure
• Datalakes
• Data Lakehouses
• Data warehouses

Scripting & Automation:

• Bash, PowerShell, Python (for automation)
• Infrastructure automation tools (e.g., Terraform, preferred)

Preferred Certifications:

• Oracle Certified Professional (OCP)
• Microsoft Certified: Database Administrator
• VMware Certified Professional (VCP)
• Red Hat Certified Engineer (RHCE)

What you'll bring:

• 15+ of experience in life sciences, pharma or biotech
• 15+ years of leadership in technology & architecture
• Ability to travel internationally as necessary.

Physical / Safety Requirements

• Position requires sitting for long hours, but may involve walking or standing for periods of time

In return, you’ll be eligible for[1]:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

About TTC

The Testing Consultancy is a global specialist software testing and quality engineering company focused on helping organizations deliver reliable, scalable, and high quality software. We partner with clients to strengthen testing practices, improve delivery confidence, and reduce risk across complex enterprise environments.

Perks of Working for TTC

• Competitive Base Salary
• Work Life Balance
• Collaborative and Supportive Culture
• Growth and Development Opportunities
• Open to FT and C2C
• Hybrid Work Model

Job Title
Senior Tosca Automation Engineer

Location
Hybrid
Candidates must be local to Columbus Ohio or Merrillville Indiana and willing to work onsite Tuesdays and Thursdays

Summary

We are seeking a Senior Tosca Automation Engineer with strong hands on experience designing, building, and maintaining automation frameworks and scripts. This role plays a key part in improving the reliability and functionality of enterprise applications, primarily across SAP and Salesforce platforms.

The ideal candidate will bring deep expertise in Tricentis Tosca, strong automation strategy experience, and the ability to collaborate across product, engineering, and QA teams. This role may also include Test Lead responsibilities, requiring leadership, coordination, and stakeholder communication skills.

Responsibilities

• Design, build, and maintain Tosca automation assets including modules, test cases, templates, and execution lists
• Serve as a subject matter expert in Tosca automation and modern testing methodologies
• Develop and enhance automation frameworks and libraries for SAP and Salesforce applications
• Execute end to end testing across SAP and Salesforce workflows, including integration scenarios
• Automate API testing using REST and SOAP services, including token handling and chained calls
• Orchestrate test execution and CI CD runs using tools such as Jenkins or Azure DevOps
• Integrate test results into qTest for reporting, traceability, and quality metrics
• Partner with product and engineering teams to ensure environment readiness and test data availability
• Drive quality metrics such as automation coverage, pass rate, defect leakage, and time to resolution
• Establish and enforce automation standards, naming conventions, and code review practices
• Mentor team members and promote best practices such as shift left and risk based testing
• Support performance and non functional testing efforts as needed
• Assist with UAT and release activities and contribute to continuous improvement initiatives
• Act as a liaison for support teams to troubleshoot incidents and provide operational support
• Communicate testing results and insights clearly to stakeholders at all levels

Qualifications

• Five or more years of experience in QA and test automation with at least three years focused on Tosca
• Strong hands on experience building and maintaining Tosca automation for enterprise applications
• Practical experience working with SAP and Salesforce platforms
• Experience with API testing including REST and SOAP, JSON and XML validation, and authentication flows
• Strong understanding of SDLC, test strategy, and automation best practices
• Experience working in Agile and DevSecOps environments
• Strong communication and stakeholder management skills

Preferred Experience

• Tricentis certifications such as Automation Specialist or Test Design Specialist
• Experience in utilities or energy domain
• Familiarity with performance testing tools such as NeoLoad
• Experience with service virtualization and test data management
• Experience optimizing automation for SAP and Salesforce environments
• Experience with mobile application testing
• Experience with qTest or similar test management tools
• Experience with CI CD pipelines and automation integration
• Familiarity with Infrastructure as Code or modern deployment practices

If your experience or qualifications is similar to our ideal of a successful candidate, please consider applying. Experience comes in many ways; skills may be transferred, but passion for your career can't be substituted. At TTC, we understand the importance of diversity and how much value it brings to the table. Diversity brings about creativity and new perspectives, which is why we beckon everyone to apply. 

We are the leader in enterprise marketing workflows. Built on ServiceNow, we provide a single platform for marketing teams to manage campaigns, projects, and marketing work.  By delivering marketing workflows in a single enterprise platform already being used by departments like IT, HR, Finance, Customer Service, and Workplace Services your company can collaborate to get work done like never before. We are a SaaS software company that provides generous compensation, excellent benefits, a stock option plan, and the opportunity to be surrounded by passionate team members who support each other. The culture offers a self-starter environment where you are challenged and have the opportunity to build something marketing teams really want to use. 

You could be a fit for our company if you champion our core values:

• Aim Higher
• If something we’re working on seems out of reach, it means we are on the right track. Our commitment to and belief in each other allows us to blow away our personal and professional goals.
• Customer Obsessed
• We work to serve and follow through on our commitments.  By serving our internal and external customers we reach our goals as a team. 
• Humble and Hungry
• If someone needs our help we will be there for them. No one is above any task and we do what is needed regardless of our title or role in the company. Together we drive for results as one team.
• Beginner's Mind
• We look at problems with an open mind and no preconceived solution.  We create breakthroughs by finding new innovative ways of operating and solving problems.
• Total Alignment
• We make sure everyone is on the same page by aligning, working towards the same goal, and achieving higher results. We operate in a culture of radical candor and open lines of communication across the business.  We have crucial conversations to address any challenges.

This position is part of the Xtern program through TechPoint. Xtern is professional development experience on top of your full-time internship with your company. Xtern provides three weekends where you will connect with other interns in tech and tech adjacent roles at companies in the Indianapolis area. Xtern weekends focus on professional development, civic engagement, and social opportunities to grow your network. You will have access to an online community, bonus fun events, and an opportunity to compete to explore Indianapolis through the Xtern Passport program.

Xtern also includes 10 weeks of free housing located at IU Indianapolis. Housing dates are from May 26th, 2026 to July 31st, 2026. You must relocate to Indianapolis for the duration of the summer to be eligible for this internship position and the Xtern program.

What You’ll Do:

• Collaboratively build new user-facing features using React and Javascript
• Participate in code reviews and pair programming with other software engineers
• Learn about cybersecurity and how it impacts software engineering
• Design, build, test, and deploy scalable APIs and custom UI components

What We’re Looking For:

• College student majoring in a technical field (IT, CS) 
• Excellent written and verbal communication and collaboration skills
• Experience writing applications with Javascript, CSS, HTML, node.js, React, and XML
• Passion for learning and growth
• Ability to work in a distributed team

Tenon is an equal-opportunity employer, and we value diversity at our company. We don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

**We are only hiring for this role in the CST or EST time zones**

At Greenlight Guru, we help the world’s most innovative medical device companies bring high-quality, life-changing products to market faster. We serve 1000+ global customers with our quality management and clinical data capture software, helping them get their products on the market and keep them there. 

When you join the team at Greenlight Guru, you’ll be a part of a collaborative, mission-driven team working in one of the most exciting and rewarding industries on the planet. Backed by JMI Equity, one of the premier growth equity firms for SaaS companies, Greenlight Guru is growing—and looking for individuals who are difference makers. Is that you?

We are looking for a commercially-minded, revenue-driven, highly technical Solutions Engineer to join our organization with a heavy focus on selling to software engineering teams. Reporting to the Director of Product Marketing, you are responsible for translating our product strategy into confident, effective value-based selling. You will work alongside Sales to support live deals, bring product and technical depth into buyer conversations, and turn field experience into reusable assets that scale across GTM. You focus on the last mile of the buying journey - proving technical fit, reducing risk, and helping buyers move forward with confidence. While you are a strategic partner to Sales on active deals, being situated within the Product Marketing team allows you to act as a critical bridge between our product’s capabilities and our market-facing message. You are a technical storyteller who knows how to connect "how it works" with "why it matters." You’ll use real-world deal experience to stress-test and refine our positioning, competitive strategy, and the assets we use to win.

Responsibilities

Value Selling & Deal Execution

You own technical confidence in active deals and are accountable for buyer certainty in our technical fit. Your performance is largely measured by your impact on revenue.

• Technical Discovery & Diagnosis: Lead additional deep-dive discovery during demos to uncover a prospect’s current tech stack and pain points. You help diagnose the technical "why" before prescribing a solution.
• Value-Based Demonstrations: Deliver demos tailored to the buyer’s specific goals and success criteria. Lead with value and differentiation, not feature walkthroughs.
• Trial & Evaluation Ownership: Own the trial experience end-to-end, including setup, guidance, and success criteria. Ensure trials clearly demonstrate value and differentiation.
• Technical Deal Support: Act as a persistent partner in the deal, not a one-time resource. Stay current on deal status, identify technical risks, and partner with AEs to move deals forward.
• Expansion & RFP Support: Support expansions and at-risk renewals. Partner with AEs and PMM to ensure RFPs have high positioning impact and technical clarity.

Technical Assets & Demo Environments

You are responsible for maintaining the "technical sales toolkit," ensuring the GTM team has accurate, field-ready assets to sell efficiently.

• Scalable Asset Creation: Build and maintain reusable technical sales assets—such as walkthroughs, video snippets, and PoC templates for APIs/integrations—that help the field scale.
• Demo Environment Ownership: Maintain stable and accessible demo environments. You ensure demo data supports realistic, value-based storytelling for our core personas.
• Demo Narrative: Collaborate with PMM to ensure the core demo narratives are technically accurate and reflect how the product is actually used in the field.

Cross-Functional Collaboration & Enablement

You act as the resident technical authority, ensuring seamless alignment between the Product, Marketing, and Sales organizations.

• Cross-Functional Collaboration: Serve as the trusted technical lead for AEs, AMs, and CSMs. You are a strong collaborator who bridges the gap between technical details and GTM strategy.
• Product Readiness: Stay current on what’s shipping and why it matters. Translate new features into demo-ready flows, technical FAQs, and narratives for the GTM team.
• Field Intelligence Loop: Serve as the "voice of the buyer." Identify patterns in technical objections or competitive gaps and provide clear, actionable feedback to Product to influence the roadmap.

Candidate Profile

• Commercially Minded: You understand that technical depth exists to win deals and drive revenue.
• Strategic Partner: You know when to lead technically and when to support the broader sales strategy.
• Solution Storyteller: You can translate product capabilities into outcomes that actually matter to a buyer.
• Ownership Mindset: You treat deals, proof points, and internal process improvements as your personal responsibility.

Qualifications

• Technical Sales Experience: Proven track record delivering value-led technical demonstrations to software engineers and highly technical buyers, translating complex platform capabilities (APIs, integrations, developer workflows) into clear business and technical outcomes.
• Software Development Fluency: Strong working knowledge of modern SDLC practices, including requirements management, Git-based version control, CI/CD workflows, and release processes, with hands-on experience using Jira and similar developer tools (e.g., issue tracking, sprint boards, workflow configuration) in real engineering environments.
• API & Integration Literacy: Practical understanding of REST APIs, authentication methods, and system integrations - confident discussing how systems connect, how data flows between platforms, and how traceability or automation is maintained.
• Code Familiarity: Hands-on familiarity with code platforms (you have written or actively used code-based tools) and can speak fluently about repositories, commits, pull requests, and automation workflows.
• SaaS Background: Experience at a small-to-mid-sized SaaS company where you helped build or refine the SE function, processes, or demo environments - not just operate within an established structure.
• Revenue Impact: A clear track record of directly supporting revenue, advancing complex opportunities, and influencing deal outcomes in partnership with Account Executives.
• Learning & Ownership Mindset: Thrives in a fast-moving, evolving environment — actively seeks feedback, adapts quickly, rolls with change, and contributes ideas that help the team continuously improve how we sell and deliver technical value.
• Nice to Have: Experience in life sciences/medtech environments or running technical proof-of-concepts.

Benefits you’ll enjoy:

• Flexible Paid Time Off policy and working hours
• Home Office stipend for new hires
• Multiple Medical Insurance options, plus Dental and Vision
• 401k (with company match) 
• Equity Program Eligibility (based on role and/or tenure)
• Paid Maternity and Paternity Leave
• Disability insurance

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

About E-gineering

E-gineering (EG) is a 100% employee-owned software consulting company based in Indianapolis, Indiana, founded in 2000. True consulting is about serving people with integrity, excellence, and a genuine heart. We stand behind our work, always do what's right, and are willing to take risks to uphold our values.

Why Join Us?

• Work-Life Balance: We maintain a strict 40-hour work week. Your personal life matters as much as your professional one.
• Award-Winning Culture: For over 13 years, we've been named one of the Best Places to Work in Indiana, consistently ranking in the top 3.
• Grace in Tough Times: Life happens. When it does, we offer grace and flexibility so you can focus on what matters most—yourself and your family.

Position Overview

• Title: Software Engineer
• Type: W-2 or 1099-Direct Employment
• Location: Indianapolis, IN (on-site)
• Relocation: Not offered
• Work Authorization: Must be authorized to work in the United States without sponsorship, as E-gineering does not provide employment sponsorship now and in the future.

E-gineering (EG) is seeking a passionate Software Engineer with a minimum of three years of experience. This W-2 position requires candidates to live near Indianapolis, IN.  

Currently, we do not provide relocation assistance. W-2 employees may work from home, at EG's Indianapolis office, or at the client's location, depending on client needs. Current opportunities allow for remote work from home. 

At E-gineering, we handle a variety of projects that include: 

• Collaborating within blended development teams to deliver software quickly using agile methods 

• Helping clients develop solid CI/CD practices and fostering a DevOps culture 

• Supporting decision-making and implementation of distributed systems for large enterprises 

• Designing solutions that create business value for clients 

• Cloud deployment and migration 

Who You Are: 

• Continuously sharpening your skills to meet our customers' needs 

• Enthusiastic about sharing knowledge and actively helping teammates grow and excel 

• Humble — prioritizing the best outcomes for customers and the team over being "right." 

What You Enjoy: 

• Working hard with a collaborative Team 

• Committed to serving clients well 

• Taking initiative to solve problems and learn new technologies 

• Assisting teammates through challenges 

What You'll Do: 

• Develop server-side solutions using languages like Java, C#, JavaScript, and Python 

• Create effective API designs with front-end teams and integrators 

• Write functional front-end code using modern JavaScript frameworks (React, Angular, Vue) 

• Communicate with business stakeholders and decision-makers about development activities and solutions 

• Advise clients on technological choices 

• Continuously explore, evaluate, and implement new technologies to enhance development efficiency 

• Learn new technologies to contribute across different parts of the software stack as needed 

What You Bring: 

• 3+ years of software development experience 

• Strong knowledge of Java, C#, or JavaScript 

• Experience with JavaScript frameworks such as Angular, React, or Vue 

• Extensive understanding of SQL and database design 

• Knowledge and experience with cloud technologies 

• Experience with Agile methodologies 

• Excellent interpersonal and communication skills 

• Comfort using LLMs and other AI tools to rapidly learn about new technologies and ramp up on new engagements 

• Comfort with Agentic AI as a tool to help build high-quality, well-engineered software 

• Familiarity with prompt, context, and agent management techniques 

• Experience with unit and integration testing and designing test systems 

• Awareness of architectural trade-offs when designing software systems 

• Ability to design and create APIs 

• Ability to collaborate well with others in a development team, respecting team members; the best teams produce quality software without toxicity. Willingness to help others and humility to ask for help when needed 

Nice to Have: 

• Experience with Python 

• Experience with distributed systems tooling like Kubernetes 

• Knowledge of messaging and event-driven technologies such as MQ or Kafka 

• Passion for DevOps tools, technologies, and culture 

• Experience with other programming platforms or languages 

• Knowledge of NoSQL databases 

Systems Engineer Responsibilities:

• Requirements & Traceability: Solicit, manage, and document stakeholder needs and requirements across constituent systems; perform requirements analysis, development, allocation, and management; create and maintain traceability from requirements (including system risk) to system verification and validation; manage requirements flow-down and interface requirements between constituent systems.
• Integration & Verification: Develop and document system test strategies; lead system integration, verification, and validation activities across constituent systems; participate in design reviews and contribute SE deliverables aligned with regulations and standards.
• System Design & Architecture: Develop and document system architecture including concept trade-offs, functional analysis, and interface definitions; apply systems thinking to understand how constituent systems interact within the broader product ecosystem; define and manage system boundaries and interfaces between constituent systems.
• Risk Management: Support system-level hazard identification and participate in risk identification, assessment, and management activities; collaborate on risk documentation and maintaining risk management files; apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle.
• Continuous Improvement & Quality: Participate in the systems engineering community of practice to stay current with tools, techniques, and regulatory expectations; drive continuous process improvement focused on SE-related processes and tools; proactively identify and communicate quality issues.

Requirements:

• Bachelor’s degree in an engineering field with 5+ years of relevant experience
• Demonstrated experience creating systems engineering work products (e.g. stakeholder requirements document, system requirements document, V&V matrices, etc)
• Proficiency with requirements management
• Strong technical writing skills for protocols, reports, and regulatory submissions
• Experience with drug delivery devices (autoinjectors, pen injectors, wearables, inhalers) or combination products
• Knowledge of ISO 14971 (risk management), ISO 13485 (quality management), and FDA 21 CFR Part 820 (design controls)
• Experience with hazard analysis techniques (FTA, FMEA) and risk management activities
• Qualified candidates must be legally authorized to be employed in the United States
• Onsite job requirement in Indianapolis, IN

Validation/CQV Engineer Responsibilities:

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment

Requirements:

• Bachelor’s Degree or equivalent required
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice training (may be completed at onboarding)
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Onsite work requirements in Indianapolis, IN

Job Summary:

We are seeking a Risk Management Project Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 1-3 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint
• Onsite job requirement in Indianapolis, IN

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Senior Automation Engineer Responsibilities:

• Automation Engineer strong in IT/IT-centric systems to help with troubleshooting, detecting issues
• Responsible for design and implementation of key automation aspects of an equipment project, often including PLC, vision, HMI programming.
• General Change management
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Independent verification of testing against specifications
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
• Running test scripts and documenting results.
• Adherence with project schedule for all assigned activities.
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team.
• Design and PLC programming (configuration of PLC program) on standard equipment/products
• Lead and perform complex quality checks which require an intricate understanding of the machine control systems and operations
• Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams
• Contribute to the completion of projects, manage own time on agreed targets, develop plans for own projects and leads small project teams
• Monitor, generate and complete the periodic review, validation master plan for the automation engineering program
• Demonstrate good planning, organizing, time management and team participation skills
• Responsible for routine and preventive maintenance work, ensure all the equipment and facilities work safely, efficiently and reliably
• Generate and develop standard operating procedures and system support
• Analyze operational process problems and recommend appropriate corrective and preventative actions
• Manage change control authoring and execution
• Participate in the site and network wide teams to provide cybersecurity alignment and direction
• Provide 24x7x365 support of automation systems and perform automation activities for capital and non-capital projects
• Modify moderately complex to highly complex control logic that requires a degree of scientific and/or manufacturing process expertise
• Clearly communicate progress and issues to peers

Requirements:

• Must have 3-5 years of industrial experience as an Automation Engineer
• Experience in creating SQL databases
• Understanding domain authentication
• Experience in working with IT to schedule implementations
• Able to complete software installs and/or updates
• Creation of databases
• Experience in upgrading system requirements for servers
• Understanding of Citrix application
• GMP and Good Documentation Practice knowledge
• Position requires onsite work in Indianapolis, IN
• Responsible for installing, maintaining, and troubleshooting automated utility, processing, filling, inspection, and packaging equipment
• Generate user requirement specifications for control systems
• Able to make minor modifications to code and HMI graphics for smaller changes
• Must be able to read logic and perform programming as well as update control system documentation
• Contribute technical content to validation protocols on automation systems and perform execution of protocols

Job Summary:

We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 3-5 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

How You'll Make an Impact: 

As a Senior Fullstack Engineer on the Distribution Team, you'll be instrumental in developing and enhancing the products that connect Cloudbeds' ecosystem to the world's largest distribution channels. You'll architect scalable solutions using modern technologies, contribute to our microservices migration, and ensure our platform delivers exceptional performance and security for thousands of properties worldwide. Your work will directly impact how hotels reach guests through integrations with major platforms like Booking.com, AirBnb and beyond.

Our Distribution Team:

We're the bridge connecting properties to the global travel ecosystem. Our team tackles complex integration challenges that directly impact revenue for thousands of hotels worldwide, from building rock-solid connections with major OTAs to ensuring every booking flows seamlessly and securely. We balance innovation with pragmatism: migrating legacy systems to modern microservices while maintaining the reliability our customers depend on. If you thrive on solving hard technical problems with real business impact and love the challenge of both building greenfield features and refactoring legacy code, you'll feel right at home here.

What You Bring to the Team:

• Design and implement robust backend features and improvements using PHP, with a strong focus on performance optimization and scalability for our distribution platform
• Build intuitive frontend experiences using React and Vue, ensuring seamless user interactions across the Cloudbeds ecosystem
• Architect secure solutions for handling financial transactions and sensitive personal data, applying security best practices throughout the development lifecycle
• Write clean, well-tested, and well-documented code with comprehensive test coverage (unit, integration, end-to-end) to maintain high quality standards
• Lead technical discussions on complex concepts and requirements with both technical and non-technical stakeholders, driving alignment on backend and frontend architecture decisions
• Contribute to our ongoing initiative to migrate core platform components into microservices, helping shape the long-term technical vision
• Re-architect and refactor existing legacy systems to align with modern standards and project requirements, demonstrating ownership and commitment to continuous improvement
• Mentor team members through pair programming and code reviews, promoting best practices that elevate code quality and team processes
• Collaborate with cross-functional teams to plan, build, and ship high-quality features that delight our global customer base

What Sets You Up for Success:

• 5+ years of PHP web application software engineering experience
• 5+ years of experience with JS frameworks, Vue.js and React are preferred
• Solid experience with modern JavaScript/TypeScript
• Strong hands-on experience with Docker and containerized development workflows
• Demonstrated expertise in performance optimization and expert knowledge of relational databases, indexing, and searching technologies
• Strong understanding of security considerations, particularly for applications handling financial transactions and personal data
• Experience with test automation across all levels (unit, integration, end-to-end) and a passion for quality-driven development
• Proven track record of taking ownership of projects and delivering results independently
• Business-level English fluency (verbal and written) and excellent communication skills for collaborating across a globally distributed, remote-first team

Bonus Skills to Stand Out:

• Experience designing and building microservices and/or micro-frontends
• Hands-on experience with PHP frameworks (CodeIgniter, CakePHP, Laravel, Symfony)
• Cloud and infrastructure experience with Kubernetes, AWS, Terraform, and Argo CD
• Experience working with event-driven architectures and messaging systems (e.g., Kafka)

Compensation: Depending on your skills and experience, you can expect your annual compensation to be between $145,000 - $165,000