Process Validation Associate II

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.

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. It interacts with the client and the cross‑functional client team members to develop process validation strategies and creates process validation protocol and summary documents. It reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

• Supports the process validation program
• Interacts with the client and client team to define process validation scope
• Designs and executes the appropriate development Technical Studies to define process parameters
• Creates a risk assessment of the process to be validated
• Creates process validation protocols
• Conducts and coordinates process performance qualification (PPQ batch) execution for new and existing products
• Prepares validation summaries
• Uses statistical tools to analyze process validation data
• Performs annual reviews / continued process verification (CPV) of validation projects
• Investigates and executes validation related Corrective and Preventive Actions (CAPA)
• Demonstrates ability to communicate effectively at all levels
• Non‑conformance Report (NCR) investigation owner for process validation related, as needed
• Participates in regulatory, client and internal audits

• BS degree, preferably in a science or engineering related field
• 5+ years pharmaceutical industry experience in parenteral manufacturing
• Experience working independently or in a team
• Knowledge of pharmaceutical manufacturing industry
• Experience executing projects
• Experience identifying opportunities for optimization of processes/projects
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• Experience using enterprise software (i.e., JDE, Veeva, Trackwise, etc.)

• May require overtime work, including nights and weekends
• Sitting for long hours and walking/standing for long periods of time
• Must be able to gown for Grade C area

• 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…