This role:

We are looking for a Commissioning, Qualification, and Validation (CQV) Principal Engineer responsible for creating and maintaining best practices for Engineering documentation generation and review within the pharmaceutical manufacturing industry, as well as equipment life cycle management. The position works closely with cross-functional teams including quality, EHS, maintenance, and manufacturing, and reports to the Director of Engineering. This position is 100% onsite at the Bloomington, Indiana facility.

The Responsibilities:
• The CQV Principal Engineer partners cross-functionally across Engineering, Maintenance, and Quality to ensure Engineering practices are compliant with procedures and Regulatory guidelines
• Serve as subject matter expert (SME) for Commissioning, Qualification, and Validation. Develops and delivers training to Engineers and applicable team members
• Authors, reviews, and approves Engineering documentation (protocols, reports, deviations, change controls, and CAPAs related to CQV scope)
• Manages team of professionals responsible for Validation Maintenance/Periodic Review program. Facilitates governance and tracks and reports progress, risks, and resource needs to leadership.
• Supports regulatory inspections and client audits. Drives and maintains Audit Readiness and leads corrective actions to closure without repeat occurrences
• Participates/collaborates with internal departments and external engineering firms in feasibility assessments, concept design, basic design and detail design

Required Qualifications:
• BS degree in Engineering, Life Sciences, or related technical field
• 10+ years experience in pharmaceutical/biotech industry preferred
• Excellent oral and written communication skills with the ability to influence cross-functional teams
• Strong organizational, planning, and project tracking skills
• Ability to manage multiple priorities in a fast-paced environment

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.