Principal Duties/Responsibilities:

To Live and Lead Safety

· Takes responsibility for employee safety and wellness by deploying the ATS safety program and ensuring effective completion of safety training, observations, and incident investigations.

· Implements and actively supports all Beyond Zero initiatives

· Enables the growth of a customer safety culture by a fostering a safety partnership and sharing best practices

To Inspire and Provide Clarity on Vision and Strategy

· Motivates employees by communicating a clear vision that enables all employees to understand the rationale for, and the benefit of, both site-level and company-wide objectives

· Acts as an effective change agent, leading the implementation of strategic initiatives through positive team communications, appropriate action planning, and successful implementation activities

· Understands and appropriately articulates both ATS and customer strategies, providing the team with line of sight between team responsibilities and strategic outcomes

To Own Our ATS Culture

· Builds positive relationships with ATS employees, customers, and peers through open communication and role-modeling the ATS leadership core competencies of honesty and respect

· Sets a positive, influential standard for others and creates a constructive climate for their team

· Influences with transparency and use participative methods to ensure that decisions are understood and accepted

· Establishes a positive work environment through managing and personalizing onboarding; engaging in ongoing one-on-one communications; and recognizing individual contributions and achievements on a timely basis

· Adheres to policies and procedures and ensures that staff understands the rationale behind policies and processes

To Support Our Employees’ Learning and Growth

· Leads and builds team capabilities by working with individuals on performance improvement, career planning, training, and skills development.

· Develops, communicates, and executes a Skills Matrix and Technician Training Plan

· Builds and maintains a succession plan for key positions (i.e., Supervisors, Supply Chain, P/S, RE)

To Ensure and Drive our Business Results

· Leads and ensures the Operating System is understood, reinforced, and embedded

· Develops and executes a site-specific maintenance plan per ATS standards

· Manages financial performance of the site (revenue, expenses, and profit) to achieve set objectives

· Develops and maintains effective relationships with all ATS business units, fully utilizing their services and ensuring cross-functional alignment

· Collaborates with and builds customer relationships to ensure priority alignment and proactively anticipates customer needs as the primary on site contact

· Ensures alignment of customer expectations and ATS site goals through management of site-specific contracts

· Communicates with the customer through daily, weekly, and monthly meetings and conducts a regular review of the performance metrics with the customer

· Drives a continuous improvement methodology and promotes cost savings

· Analyzes and reports on key performance indicators, completing root cause analyses and developing and executing action items while removing barriers and addressing issues

· Collaborates with sales and operations leadership to increase the scope of services

Knowledge, Skills, Abilities (KSAs), & Competencies:

Essential KSAs:

· Bachelor’s degree in technical, business, or a related field preferred or seven years of operations / maintenance experience

· Three years of supervisory experience with a strong focus on development of employees

· Resilient and flexible, able to multitask and prioritize with an innate ability to understand and accept change and motivate others around change

· Highly tuned emotional intelligence with demonstrated ability to build relationships and lead teams with honesty and integrity to achieve goals

· Solid understanding of manufacturing / assembly work environment

· Business acumen

· Positive influencer with appropriate levels of organization.

· Strong customer focus with the ability to build positive business relationships and show a sense of urgency

Desirable KSAs

· Manufacturing maintenance experience preferred with related certifications and training

· Good understanding of, and/or experience with, proactive/reliability maintenance processes, i.e., Planning/Scheduling, P/M, PdM, and root cause analysis, and continuous improvement methodologies

· Good computer skills, including Microsoft applications and web-based applications such as Power BI, GEAC, Concur, Workday and related software

· Time management skills

· Ability to relocate to specified locations

· Excellent communications skills (verbal, written, and presentation)

· Agile, curious learner and authentic, credible teacher

· Financial acumen and knowledge of forecasting and managing budgets

Leadership Core Competencies:

Business and Company Acumen

Lead with honesty and integrity

Build bold and relevant strategies

Welcome and motivate change

Recognize the right outcomes and how they were achieved

Role model safety and wellness

Emotional Intelligence

Provide psychological safety

Be self-aware

Build relationships

Ask for and act on feedback

Respect diverse background and viewpoints

Lead in the Present; Eye to the Future

Commit to accountability

Coach people to their potential

Own talent development and placement

Turn problems into opportunities

Be resilient and flexible

Communicate, Communicate, Communicate

Practice transparency

Build relationships through respect

Be a curious learner and credible teacher

Influence in a proactive, positive way

Ensure cross functional awareness/decisions

ATS is committed to providing equal employment opportunities in all aspects of employment to all applicants and employees without regard to age, color, race, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, disability, veteran status, genetic information, or other legally protected status. Review the privacy policy here.

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:

The Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development, equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support. This position reports to the Manager, Packaging Validation. 

The responsibilities:

• Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
• Develops and executes Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc.
• Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
• Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders.
• Formulates and recommends validation procedures and technical work in accordance with project and business objectives
• Participates in client and regulatory audits
• Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications
• Acts as Change Control Management (CCM) Owner, Non-Conformance and OCR (Out of Control Report) author
• Identifies and implements changes to Automated Inspection Machines
• Reviews and approves Packaging Technical Services documents

  Desired qualifications:

• Bachelor’s degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required.
• In-depth process knowledge of related manufacturing equipment and process preferred
• Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
• Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
• Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.)
• Manages time effectively and independently within assigned responsibilities
• Ability to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelines
• Operates as a self-starter having the ability to complete tasks with minimal direction from manager
• Exhibits a sense of urgency to meet timelines and key milestones
• Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones

  Physical / Safety Requirements:       

• Must be able to lift up to 25 lbs.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting/standing for long hours, but may involve walking or standing for periods of time
• Must wear appropriate Personal Protective Equipment as applicable
• Must fully understand company safety rules and regulations

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
  • Employee Ownership Plan
• 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/

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