About The Position

Clinical Architecture is seeking a Software Test Lead to join our team in the Indianapolis, IN area. The Software Test Lead will have experience with healthcare messaging and will oversee quality assurance initiatives across our software products. The ideal candidate will bring expertise in validating complex healthcare systems, ensuring data integrity, and supporting interoperability workflows. This role requires strong analytical thinking, hands-on testing skills, and the ability to collaborate across Engineering, Product, and Automation teams to drive a culture of quality.

• This role is required to be on site at our Carmel, IN Headquarters. Clinical Architecture offers ample flexibility to accommodate a healthy work-life balance. 
• Applicants must be authorized to work in the U.S. without sponsorship. 
• Providing false information on application questions may result in automatic dismissal of your application. Please answer questions truthfully and to the best of your ability.

Responsibilities

Quality Assurance and Testing:

• Analyze software requirements to ensure clarity, completeness, and testability.
• Design, document, and maintain comprehensive test cases and support test artifacts.
• Execute tests to validate functionality, usability, and overall product quality.
• Perform exploratory, ad-hoc, regression, load, and system testing.
• Validate software performance across multiple environments.

Defect Management and Validation:

• Detect, report, and track defects throughout the development lifecycle.
• Re-test resolved defects to ensure proper fixes are implemented.
• Traverse and validate database entries using SQL queries.
• Research and replicate customer-reported issues to support effective troubleshooting.

Collaboration and Communication:

• Conduct peer reviews of test plans, requirements, and design documents.
• Participate in design reviews to ensure quality standards are embedded early.
• Communicate effectively with Engineering regarding system issues and defects.
• Partner with Product Management to clarify requirements and identify gaps.
• Review end-user documentation, providing guidance on content accuracy and usability.

Process Improvement and Leadership:

• Provide insights and recommendations to improve Product Quality processes and efficiency.
• Support the Automation team by supplying test scenarios, use cases, and test data.
• Develop deep understanding of Clinical Architecture’s products and workflows.
• Champion a culture of quality across the organization.

Qualifications

• Associate degree in Computer Science, Information Technology, or equivalent work experience.
• 5+ years of experience testing applications for usability, functionality, and performance.
• Hands-on experience validating software using SQL queries.
• CTFL or equivalent QA certification preferred.
• Experience with API testing, including test tools such as Postman, Swagger, or automation frameworks preferred.
• Coding or scripting experience preferred.
• Healthcare messaging experience (e.g., HL7, FHIR, CCD, X12) preferred.

Required:

• 3+ in Windows desktop application development using Windows App SDK, WinUI (or similar), C#, XAML — and ideally additional experience with native Windows code (C++, Win32/WinRT/COM).
• Deep understanding of Windows application architecture, including interop between managed code (.NET) and native code.
• Proven track record of designing, building, and shipping production-quality desktop applications, with an emphasis on reliability, performance, scalability, and maintainability.
• Strong experience with accessibility APIs on Windows (e.g. Microsoft UI Automation or similar), and a dedication to building accessible and inclusive software.
• Excellent software engineering fundamentals: OOP, design patterns, data structures, algorithms, memory management, multi-threading or asynchronous programming (where relevant).
• Experience leading technical design, mentoring other engineers, conducting code reviews, and making architecture-level decisions.
• Strong communication skills; ability to articulate tradeoffs, collaborate with cross-functional teams, and drive consensus.
• A user-centric mindset: focus on building polished, intuitive, and accessible experiences for end users.

Preferred / Bonus:

• Experience with writing automated tests for UI — unit tests, integration tests, UI automation tests; familiarity with relevant testing frameworks.
• Experience with performance optimization for desktop apps (memory usage, startup time, rendering performance, high-DPI support, responsiveness under load).
• Experience with localization/globalization, right-to-left UI support, internationalization, accessibility for multiple regions.
• Familiarity with telemetry, analytics, crash reporting, logging, and error monitoring in desktop applications.
• Previous experience in shaping CI/CD workflows, release pipelines, and deployment strategies for desktop applications.
• Demonstrated ability to take ownership of feature areas or modules and drive them long-term, including maintenance, refactoring, and technical debt management.

What we offer

• A high-impact role: you will define architecture, shape the future of our Windows product, and directly influence what millions of users see and experience.
• A collaborative, flat-structure engineering culture — you are not just a coder, but a builder and a decision-maker.
• Opportunities to lead — mentor others, steer technical direction, and grow into broader technical leadership (e.g. Tech Lead, Architect).
• Flexibility, autonomy, and responsibility: you define how to solve problems, own features end-to-end, and contribute to long-term product vision.
• A purpose-driven mission: building software that’s reliable, accessible, and user-centered — making a real difference for people.

The United States Based Salary range for this role is: 140,000-200,000 USD/Year + Bonus + Stock depending on experience             

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Speechify is committed to a diverse and inclusive workplace. 
Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
• Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)

Deviation Management

• Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
• Ensure deviations are thoroughly documented, investigated, and closed within required timelines
• Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations

CQV & Compliance Support

• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support validation impact assessments and execution activities related to changes
• Review and approve validation and technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams 
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry
• Strong experience with:
  • Change control systems
  • Deviation investigations and root cause analysis
  • cGMP and GDP environments
• Familiarity with device assembly/packaging operations is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN

About the Job

This is a high-impact leadership role responsible for end-to-end supply chain and logistics operations supporting our manufacturing site and patient-facing fulfillment. As the Director of Supply Chain and Logistics, you will lead material planning, procurement, inventory management, cold chain logistics, and order fulfillment to ensure reliable, compliant, and efficient product delivery.

You will partner closely with Manufacturing, Quality, Engineering, MSAT, Sales, and Commercial teams to ensure seamless integration between supply and demand, positioning Supply Chain and Logistics teams as both an operational backbone and a strategic enabler of growth. As a key member of the Site Operations Team and leader of our Downstream Core Team, you will drive disciplined execution, visibility, and continuous improvement across the organization.

This role is ideal for a leader who thrives in complex, regulated environments, builds scalable systems, and is energized by ensuring life-saving products reach patients reliably and on time. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Supply Chain, Operations, Engineering, Business, or related field
• 10+ years of experience in supply chain, logistics, or operations in a regulated manufacturing environment (pharma, biotech, medtech preferred)
• 5+ years of people management experience leading supply chain or logistics teams
• Strong understanding of GMP/GTP requirements as they relate to materials, storage, and distribution
• Experience with inventory planning, procurement, and supplier management including ERP/MRP systems and inventory planning tools
• Proven track record of improving service levels, reducing shortages, and optimizing inventory
• Strong analytical, problem-solving, and communication skills

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing environments
• Experience with cold chain, time-sensitive distribution, and external logistics provider management
• Familiarity with S&OP/S&OE processes and cross-functional demand–supply alignment
• Experience driving supply chain optimization through automation, digital tools, or advanced analytics
• Lean or Six Sigma certification with demonstrated application in supply chain environments
• Experience supporting regulatory inspections (FDA, AATB, or equivalent)

Key Responsibilities

• Lead, mentor, and develop a high-performing supply chain and logistics teams across procurement, planning, inventory, and fulfillment
• Own end-to-end material flow from supplier through manufacturing to patient delivery
• Ensure reliable supply of materials and on-time fulfillment of finished goods to meet patient demand
• Establish and maintain inventory strategies that balance availability, risk, and working capital
• Oversee cold chain logistics, shipping, and distribution, ensuring product integrity and compliance
• Manage supplier relationships, including performance, risk, and continuity of supply
• Drive S&OE processes to align demand, supply, and execution across the site
• Identify and mitigate supply chain risks, including shortages, delays, and capacity constraints
• Partner with Manufacturing, QA, and Engineering to support production and capacity scaling
• Lead continuous improvement initiatives to increase service level, reduce cost, and improve efficiency
• Ensure compliance with GMP/GTP, internal procedures, and regulatory expectations
• Support audits and represent Supply Chain during regulatory inspections
• Develop long-term supply chain strategy aligned with commercial growth and new product launches
• Lead the site’s cross-functional Downstream Core Team, overseeing Release and Distribution processes to ensure reliable, compliant product availability
• Travel (domestic and international) when required (<10%) to support supply chain and logistics planning or projects

In your first six months some projects you’ll work on include:

• Assess current inventory levels, service levels, and supply chain risks across all products
• Strengthen supplier management and sourcing strategies for critical materials
• Optimize cold chain logistics performance, including carrier reliability and cost
• Develop a 12-24 month supply chain roadmap aligned with growth and product launches

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

About the Job

This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Senior Manager of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow.

You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site.

This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment
• 4+ years of people management experience leading engineers or technical staff
• Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
• Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
• Proven track record of improving equipment reliability and reducing unplanned downtime
• Strong project management, documentation, and communication skills
• Experience with root cause analysis, FMEA, and SOP development
• This position is based full time onsite in our Indianapolis facility

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas
• Familiarity with computerized maintenance management systems (CMMS)
• Experience leading capital projects and facility expansions
• Lean or Six Sigma certification
• Experience implementing automation and digital engineering solutions
• Experience interacting with regulatory inspectors (FDA, EMA, or equivalent)
• Expertise in business intelligence and analytics (Tableau, Power BI, SQL)

Key Responsibilities

• Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
• Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
• Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement
• Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved
• Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk
• Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
• Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures
• Lead root cause investigations related to equipment, utilities, and facility systems
• Drive data-based reliability improvements using trend analysis and KPIs
• Support inspection readiness and represent Engineering during regulatory audits
• Develop long-term facility and infrastructure strategy aligned with commercial growth plans
• Travel (domestic and international) when required (<10%) to support other sites

In your first six months some projects you’ll work on include:

• Assessing current equipment reliability, PM effectiveness, and engineering KPIs
• Implementing a new CMMS software platform
• Identifying and prioritizing capital investments to support production growth
• Standardizing engineering documentation and technical standards
• Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements