Piper Companies is currenlty seeking experienced 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 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 CQV Engineer:
BS in a scientific discipline with 2-5 years of experience working with CQV services for equipment/instruments. Experience with COTS systems and embedded software/computer systems. Strong knowledge of temperature mapping and Kaye systems. Ability to follow and execute existing SOPs for second-in-kind equipment/instruments. Compensation of the CQV Engineer:
Compsenation: $35-$50/hr depending on years of experience Benefits: Health, Dental, Vision, 401k, PTO, and sick leave as required by law This job opens for applications on 1/17. Applications for this job will be accepted for at least 30 days from the posting date.