What are the responsibilities and job description for the Commissioning Engineer position at United Pharma Technologies Inc?
Role: CQV Engineer
Location: Bloomington, IN| Onsite
Job Description:
We are seeking a highly experienced Commissioning, Qualification & Validation (CQV) Engineer with approximately 10 years of pharmaceutical manufacturing experience to support a leading CDMO .
Key Responsibilities
- Develop, review, and execute CQV documentation including IQ/OQ/PQ protocols and reports
- Lead commissioning and qualification activities for large-scale manufacturing equipment
- Support fill/finish operations, including aseptic processing lines
- Perform qualification of lyophilizers (freeze dryers) and associated systems
- Collaborate cross-functionally with engineering, manufacturing, quality, and validation teams
- Ensure compliance with cGMP, FDA, and regulatory standards
- Support deviation investigations, change controls, and CAPA as needed
Required Qualifications
- 10 years of CQV/Validation experience in pharmaceutical manufacturing (NOT biotech or medical device)
- Strong hands-on experience with:
- Fill/Finish lines (aseptic processing)
- Lyophilization equipment
- Proven expertise in documentation development & execution (protocols, reports)
- Experience working in CDMO environments (prefered)
- Deep understanding of GMP/FDA compliance
Preferred Skills
- Experience with sterile manufacturing environments
- Familiarity with risk-based validation approaches (e.g., ASTM E2500)
- Strong stakeholder communication and project coordination skills