Sterile Inspection Process Engineering Lead

Pfizer, S.A. de C.V; Kalamazoo (MI); Hybrid; USD 99,000 - 165,000; Full time

Job summary

Pfizer is seeking a Manager, Process Engineering - Sterile Inspection to provide technical leadership for drug product inspection operations. The role partners with shop floor and supervision to ensure safe, compliant, and efficient inspection of injectable products.

The site SME for inspection technologies supports junior colleagues. The position requires a strong background in sterile inspection, cGMP manufacturing, and cross-functional collaboration to drive process improvements and cost

Qualifications

• Bachelor's degree with required experience or higher degrees as specified in basic qualifications.
• Sterile inspection practices, processes, and equipment knowledge is required.
• Pharmaceutical manufacturing experience in a cGMP environment is required.

Responsibilities

• Conduct tests and measurements during inspection to control variables (visual, physical, spectroscopy).
• Perform root-cause analyses for high-complexity deviations and implement corrective actions with cross-functional teams.
• Review unit/divisional/site docs (SOPs, User Guides, Job Aids) with input from cross-functional members.
• Support safety by identifying improvements and applying engineering controls to ensure regulatory compliance.
• Lead technical improvement projects using Six Sigma to reduce defects and increase equipment utilization.
• Train operations staff on equipment operation and safe practices.
• Identify cost-saving ideas and projects to increase equipment capacity.
• Develop and validate manufacturing processes for drug products during tech transfer.

Skills

Six Sigma

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

AVI on Korber Seidenader

Job description

Pfizer is seeking a Manager, Process Engineering - Sterile Inspection to provide technical leadership for drug product inspection operations. The role partners with shop floor and supervision to ensure safe, compliant, and efficient inspection of injectable products.

The site SME for inspection technologies supports junior colleagues. The position requires a strong background in sterile inspection, cGMP manufacturing, and cross-functional collaboration to drive process improvements and cost