Lead Process Engineer - Sterile Inspection & Automation

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

Benefits offered by this job

401(k) with Pfizer Matching

Pfizer Retirement Savings Contribution

Paid vacation

Holiday and personal days

Caregiver/parental and medical leave

Health benefits (medical, dental,視on)

Job summary

Pfizer is seeking a skilled specialist to provide technical expertise in Drug Product Operations, with emphasis on sterile inspection. You will partner with shop floor colleagues to ensure safe, compliant inspection of injectables and lead tech development for junior staff.

The role requires strong problem-solving skills, Six Sigma experience, and a track record of driving process improvements in a GMP environment. Occasional travel and weekend coverage may be needed.

Qualifications

• Bachelor's degree with at least 4 years of experience, or a master's with 2+ years, or a PhD with 0+ years.
• Sterile inspection knowledge and experience in pharmaceutical manufacturing are required.
• Experience in a cGMP environment and strong technical skills.
• Six Sigma Black Belt is preferred; cross-functional exposure highly valued.

Responsibilities

• Conduct tests and measurements across inspection stages to control variables in visual, physical, and spectroscopy-based systems.
• Lead root-cause analysis for complex deviations and implement corrective actions with engineering, maintenance, quality, and validation teams.
• Prepare and review SOPs, user guides, and job aids with cross-functional input while ensuring safety and compliance.
• Identify safety improvements and implement controls to protect personnel and ensure regulatory compliance.
• Lead technical improvement projects to reduce defects and improve equipment reliability and utilization using Six Sigma tools.
• Train operations staff on equipment operation and safe practices.
• Identify cost-saving opportunities and efficiency improvements to increase equipment capacity.
• Develop and validate manufacturing processes for drug products, including technology transfer considerations.

Skills

Sterile inspection knowledge

Six Sigma

Technical leadership

Problem solving

Education

Bachelor's degree + 4+ yrs exp

Master's degree + 2+ yrs exp

PhD + 0+ yrs exp

Associate's degree + 8 yrs exp

High school diploma + 10 yrs exp

Tools

Korber Seidenader AVI

AVI recipe development

Six Sigma methods

Job description

Pfizer is seeking a skilled specialist to provide technical expertise in Drug Product Operations, with emphasis on sterile inspection. You will partner with shop floor colleagues to ensure safe, compliant inspection of injectables and lead tech development for junior staff.

The role requires strong problem-solving skills, Six Sigma experience, and a track record of driving process improvements in a GMP environment. Occasional travel and weekend coverage may be needed.