Validation (CQV) Engineer II

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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:

he Validation (CQV) Engineer II is a key member of the Engineering team. The candidate must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to commissioning qualification and validation (CQV) process. This position works directly with the Engineering department and other functional areas and is considered the lead validation resource. The Validation Engineer II understands industry best practices and maintains a state of audit readiness always. This position reports to the Director of Engineering and is 100% onsite at the Bloomington Indiana facility.

Theresponsibilities:

• Develop documentation for CQV activities (URS Trace Matrix IQOQ Protocols etc)
• Write and execute protocols (field verification)
• Develop summary reports and analyze results to ensure compliance with cGMP and regulatory requirements
• Track validation activities and accurately report out on progress and anticipated timelines
• Manage change controls and assess for validation impacts
• Continuously interact with all levels of management ensuring effective ongoing communications across teams and stakeholders
• Anticipate potential conflict situations and manages to a successful outcome
• Assist Project Manager to ensure identification and communication of projects risks development of risk plan and leads team in the proactive management of risk response strategies
• Assist Project Managers to create/maintain project schedules and track team deliverables for project completion
• Participates in Internal/Client/Corporate/Regulatory Agency audits

Required qualifications:

• BS degree in an Engineering or Science discipline
• 2 years experience in commissioning qualification and validation in a regulated industry
• Familiarity with ISPE Baseline Guide 5
• Experience managing multiple projects in different stages at the same time
• Strong technical writing skills
• Advanced proficiency in Microsoft Office Suite
• Preferred experience in:
  • Facilities and equipment startup
  • Fill equipment (Pre-filled Syringe filler vial filler Lyos)
  • Walk-downs and troubleshooting
  • Utilities (WFI Clean Steam HVAC)
  • Building automation
  • Pharmaceutical manufacturing processes
  • Computer system validation

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Duties may require overtime work including nights and weekends
• Must be able to gown qualify for Grade A/B/C/D areas

In return youll 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
  • Short and Long-Term Disability 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
  • 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 12/31/25

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.

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