Senior CQV Engineer
Holly Springs, NC
Job Id:
139366
Job Category:
Job Location:
Holly Springs, NC
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Madalyn Barry
Piper Companies is seeking a Senior CQV Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Holly Springs, North Carolina (NC). The Senior CQV Engineer will ideally have proven expertise in commissioning, qualification, and validation (CQV) of large-scale biopharmaceutical process equipment, who can lead teams, ensure compliance, and drive operational excellence. This role is critical to ensuring the successful commissioning and validation of our biopharmaceutical manufacturing processes.
Responsibilities of the Senior CQV Engineer include:
- Lead and manage CQV activities for large-scale process equipment, including upstream, downstream, and CIP systems, ensuring timely project completion within budget and schedule constraints.
- Develop and execute validation protocols (IQ, OQ, PQ), maintain detailed documentation, and ensure compliance with GMP regulations and quality standards.
- Collaborate with cross-functional teams to troubleshoot and resolve equipment and process validation issues, while participating in risk assessments and implementing corrective actions.
- Provide technical expertise and mentorship to junior engineers, fostering team development and supporting regulatory compliance efforts.
Qualifications for the Senior CQV Engineer include:
- 7-10 years of CQV experience with large-scale process equipment in a biopharmaceutical or pharmaceutical manufacturing environment.
- Strong knowledge of upstream, downstream, and CIP systems.
- Bachelor's degree in Engineering, Biotechnology, or a related field. Advanced degree preferred.
Compensation for the Senior CQV Engineer:
- Salary Range: $85-$95/hour (USD)
- Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K
This job opens for applications on 4/4. Applications for this job will be accepted for at least 30 days from the posting date.