Senior CQV Engineer

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 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.

Application Details: This job opens for applications on 4/7 . Applications for this job will be accepted for at least 30 days from the posting date.

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