simtra usBloomington, IN
Principal CQV Engineer
Principal CQV Engineer
Principal CQV Engineer
simtra usBloomington, IN
yesterday
Pharmaceutical Preparation ManufacturingBiological Product (except Diagnostic) ManufacturingResearch and Development in Biotechnology (except Nanobiotechnology)
Apply for this role →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 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 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 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.
Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
Also on the board Same function, level within a rung
Level
Manager
Location
Bloomington, IN
Occupation
Validation Engineers
Industry
Pharmaceutical Preparation Manufacturing
Posted
yesterday