What are the responsibilities and job description for the CQV Engineer position at Piper Companies?
Piper Companies is currently seeking experienced Senior CQV Engineer professionals for a biotechnology company developing precision genetic medicines through the use of base editing technology in Durham, NC. The primary focus is on-site CQV (Commissioning, Qualification, Validation) services for equipment / instrument support, with emphasis on new equipment / instrument qualifications (CapEx) and additional operational activities (OpEx).
Responsibilities of the Senior CQV Engineer :
- Provide CQV services for equipment / instruments at both MA and NC sites.
- Perform equipment / instrument qualifications, re-qualifications, and periodic reviews.
- Ensure compliance with existing SOPs using a family approach for second-in-kind systems.
- Conduct temperature mapping for relevant systems, with preference for Kaye experience.
- Work with COTS systems, including those with embedded software / computer systems.
- Support CapEx projects for new equipment / instrument qualifications.
- Assist with OpEx activities such as re-qualifications and periodic reviews.
- Maintain work to current Good Manufacturing Practices (cGMP).
- Ensure regulatory audit readiness at all times.
Qualifications of the Senior CQV Engineer :
Compensation of the Senior CQV Engineer :
Keywords : CQV Services, Equipment Qualifications, Re-qualifications, Periodic Reviews, SOP Compliance, Temperature Mapping, Kaye Systems, COTS Systems, Biotechnology, Pharmaceutical Manufacturing
This job opens for applications on 1 / 17. Applications for this job will be accepted for at least 30 days from the posting date.
LI-KI1 #LI-ONSITE
Salary : $50 - $60
