Senior CQV Engineer

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 Boston, MA. 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:

• BS in a scientific discipline with 5-7 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.
• Excellent organizational and communication skills.
  
  

Compensation of the Senior CQV Engineer:

• Compensation: $50-$60/hr depending on years of experience
• Benefits: Health, Dental, Vision, 401k, PTO, and sick leave as required by law
  
  

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.