Validation; CQV Engineer II

About Simtra Bio Pharma Solutions

Simtra Bio Pharma 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  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.

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.

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.

• 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 manage 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
• Participate in Internal/Client/Corporate/Regulatory Agency audits

• 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

• 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

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