Lead Process Engineer, Sterile Inspection & Automation

Pfizer; Kalamazoo (MI); On-site; USD 99,000 - 165,000; Full time

Benefits offered by this job

Relocation assistance

Benefits package

Job summary

Pfizer in Kalamazoo, MI seeks a technical expert for Drug Product Operations focusing on sterile inspection. You will partner with shop floor teams, troubleshoot equipment, mentor junior staff, and drive compliance with Pfizer Quality Standards across a range of injectable products.

Responsibilities include evaluating inspection systems, investigating deviations, and developing safe, efficient, and compliant processes while identifying cost savings and capacity improvements.

Qualifications

• Degree/experience combinations meet job entry criteria.
• Sterile inspection practices and cGMP context are required.
• Pharmaceutical manufacturing experience is essential.

Responsibilities

• Test and tune visual, physical, and spectroscopy-based inspection systems.
• Perform complex deviation investigations and implement corrective actions.
• Review SOPs, user guides, and job aids for safety and compliance.
• Support safety and process improvement initiatives and controls.
• Lead Six Sigma-driven projects to reduce defects and improve reliability.
• Train operations staff on equipment operation and procedures.
• Identify cost-saving opportunities and efficiency gains.
• Develop and validate drug product manufacturing processes.

Skills

Sterile inspection

Six Sigma

cGMP compliance

Equipment troubleshooting

Education

Bachelor's degree + 4+ years

Master's degree + 2+ years

PhD + 0+ years

Associate's degree + 8 years

High school diploma + 10 years

Tools

Korber Seidenader equipment

Job description

Pfizer in Kalamazoo, MI seeks a technical expert for Drug Product Operations focusing on sterile inspection. You will partner with shop floor teams, troubleshoot equipment, mentor junior staff, and drive compliance with Pfizer Quality Standards across a range of injectable products.

Responsibilities include evaluating inspection systems, investigating deviations, and developing safe, efficient, and compliant processes while identifying cost savings and capacity improvements.