Senior CQV Engineer (Biopharma) Position Available In Wake, North Carolina

Piper Companies is actively seeking a Senior CQV (Commissioning, Qualification, and Validation) Engineer to join our team. The ideal candidate will have 7-10 years of CQV experience with large-scale process equipment, including upstream, downstream, and CIP (Clean-In-Place) systems. This role is critical to ensuring the successful commissioning and validation of our biopharmaceutical manufacturing processes. This is a Monday – Friday, traditional hours role located on-site in the greater Raleigh, NC area. Responsibilities of the

Senior CQV Engineer :

Lead and manage CQV activities for large-scale process equipment, including upstream, downstream, and CIP systems. Develop and execute CQV protocols, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Collaborate with cross-functional teams to ensure equipment and processes meet regulatory and quality standards. Troubleshoot and resolve issues related to equipment and process validation. Maintain detailed documentation of CQV activities and ensure compliance with GMP (Good Manufacturing Practice) regulations. Provide technical expertise and guidance to junior engineers and other team members. Participate in risk assessments and implement corrective actions as needed. Ensure timely completion of CQV projects within budget and schedule constraints. Qualifications of the

Senior CQV Engineer :

Bachelor’s degree in Engineering, Biotechnology, or a related field. Advanced degree preferred. 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. Proven track record of successful CQV project management. Excellent problem-solving and analytical skills. Strong communication and interpersonal skills. Ability to work effectively in a team-oriented environment. Knowledge of regulatory requirements and GMP standards. Compensation of the

Senior CQV Engineer :

$70-$85/hr depending on years of experience.

Benefits:

Medical, Dental, Vision, 401k, and sick leave if required by law.

Keywords:

CQV, Commissioning, Qualification, Validation, Biopharmaceutical, GMP, Upstream, Downstream, CIP, Project Management, Regulatory Compliance, Risk Assessment. This job opens for applications on 5/22/2025 . Applications for this job will be accepted for at least 30 days from the posting date. #LI-PB2 #LI-ONSITE