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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.