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
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.
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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