Lead Process Engineer – Sterile Inspection Tech

Pfizer; Michigan; On-site; USD 99,000 - 165,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching

Health benefits

Paid vacation & holidays

Relocation assistance

Job summary

Pfizer in the United States is seeking a technical operations expert for Drug Product Operations, focusing on sterile inspection of injectable products. You will partner with shop floor teams to ensure safe, compliant inspection and support equipment troubleshooting.

As a site SME, you will develop processes, lead Six Sigma projects, train colleagues, review SOPs, and contribute to safety, quality, and efficiency.

Qualifications

• Bachelor's degree with 4+ years of experience.
• Master's degree with 2+ years of experience.
• PhD with 0+ years of experience.
• Associate's degree with 8 years of experience.
• High school diploma (or equivalent) with 10 years of relevant experience.
• Specific knowledge of sterile inspection practices, processes, and equipment is required.
• Pharmaceutical manufacturing in a cGMP environment is required.

Responsibilities

• Conduct tests and measurements to control variables in inspection systems.
• Perform root-cause analysis using Six Sigma tools and implement corrective actions.
• Review SOPs, User Guides, and related documentation with cross-functional teams.
• Support safety by implementing engineering and procedural controls.
• Lead technical improvement projects to reduce defects and improve equipment use.
• Train operations staff on equipment operation aspects.
• Identify and implement cost-saving ideas to increase capacity.
• Develop and validate manufacturing processes for drug products.
• Prepare for audits and respond to regulatory observations.

Skills

Sterile inspection expertise

Six Sigma knowledge

cGMP experience

Analytical problem solving

Education

Bachelor's degree

Master's degree

PhD

Associate's degree + 8 years experience

High school diploma + 10 years experience

Tools

AVI recipe development

Korber Seidenader equipment

Six Sigma tools

Job description

Pfizer in the United States is seeking a technical operations expert for Drug Product Operations, focusing on sterile inspection of injectable products. You will partner with shop floor teams to ensure safe, compliant inspection and support equipment troubleshooting.

As a site SME, you will develop processes, lead Six Sigma projects, train colleagues, review SOPs, and contribute to safety, quality, and efficiency.