Quality Validation Lead – Engineering (GxP)

ManpowerGroup; Swiftwater (Monroe County); On-site; USD 107,000 - 145,000; Full time

Job summary

ManpowerGroup in Swiftwater, PA seeks a USA-Quality Manager III (Engineering) to lead quality validation activities across manufacturing and engineering teams, ensuring compliance with GxP, FDA, GMP, and QSR standards.

The role requires a Bachelor's in Engineering or Life Sciences with 6–9 years in regulated manufacturing, strong CAPA leadership, and excellent communication and problem-solving skills to drive continuous improvement and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline
• 6–9 years of experience in pharmaceutical, biopharmaceutical, or highly regulated manufacturing environments
• Strong background in quality validation, quality systems, and regulatory compliance in life sciences
• Proven experience leading CAPA investigations with root-cause analysis and corrective actions
• Excellent communication, analytical, and problem-solving skills with ability to manage multiple projects

Responsibilities

• Lead and manage quality validation activities across manufacturing and engineering teams to ensure compliance with industry standards and regulations.
• Support validation efforts for equipment, processes, facilities, and computerized systems, including documentation review and approval.
• Oversee and investigate CAPA activities, ensuring root cause analysis and effective corrective actions are implemented.
• Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Validation, Regulatory Affairs) to drive continuous improvement.
• Maintain knowledge of GxP, FDA, GMP, and QSR regulations to ensure ongoing compliance and best practices.

Skills

Leadership

Communication

Analytical thinking

Problem-solving

Multi-project management

Education

Bachelor's degree in Engineering

Master’s degree preferred

Job description

ManpowerGroup in Swiftwater, PA seeks a USA-Quality Manager III (Engineering) to lead quality validation activities across manufacturing and engineering teams, ensuring compliance with GxP, FDA, GMP, and QSR standards.

The role requires a Bachelor's in Engineering or Life Sciences with 6–9 years in regulated manufacturing, strong CAPA leadership, and excellent communication and problem-solving skills to drive continuous improvement and regulatory compliance.