Manager, Process Engineering - Sterile Inspection

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

Use Your Power for Purpose Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on members who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always strive to improve outcomes. You will help ensure that patients and physicians have the medicines they need when they need them. Your role is crucial in making sure our innovations reach those who need them most. By being part of our team, you contribute to a mission that values dedication and agility, ensuring that every patient receives the best possible care.

ROLE SUMMARY

Provides technical expertise and operational support for Drug Product Operations, with focus on sterile inspection operations. Partners with shop floor colleagues and supervision to ensure safe, compliant, and efficient inspection of a diverse mix of injectable products. Assists in equipment and process troubleshooting activities as needed. Serves as a key technical subject matter expert within the site for inspection technologies. Responsible for technical development of junior colleagues.

ROLE RESPONSIBILITIES

• Conducts tests and measurements throughout stages of inspection to determine control over applicable variables, including tuning of visual, physical, and spectroscopy-based inspection systems.
• Investigates deviations of high complexity, involving multiple departments/sites, with significant scope that occur on the manufacturing floor. Performs root-cause analysis using Six Sigma tools, and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
• Authors and performs periodic reviews of unit/divisional/site documentation, including SOPs, User Guides, Job Aids, etc., and gathers input from cross-functional team members to ensure safe, efficient, and compliant practices.
• Supports safety team by proactively identifying improvement opportunities and implementing engineering, protective, and procedural controls to improve the safety of colleagues working in the area and ensure compliance with applicable regulations.
• Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization, and uses Six Sigma tools to investigate common cause process variation.
• Responsible for training operations colleagues on aspects of equipment operation.
• Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
• Develops and validates manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.
• Responsible for audit preparation, documentation, follow up for unit operations. Present investigations, procedures or practices to auditors, and acts as an SME for tours and discussions. Responsible for developing compliance gap assessments and responses for Pfizer Quality Standards or for Regulatory Observation Network Assessments, and for developing strategies for complying with evolving compliance expectations.
• Contributes to master planning exercises by maintaining matrices of unit capabilities, gaps, and needs. Applies expertise of product/technology compatibility for feasibility assessments.
• Contributes SME knowledge on emerging technologies and develops and shares best practices with PGS network or industry communities of practice.
• Serves as a key site technical SME for automated visual inspection technologies, and other key physical or spectroscopy-based inspection technologies.
• Responsible for technical development of junior colleagues.

BASIC QUALIFICATIONS

• Applicant must have a bachelor's degree with at least 4 years of experience.
• OR a master's degree with at least 2 years of experience.
• OR a PhD with 0+ years of experience.
• OR an associate's degree with 8 years of experience.
• OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Specific knowledge of and experience with sterile inspection practices, processes, and equipment are required.
• Pharmaceutical and manufacturing experience, and strong, demonstrated technical skills exhibited in a cGMP environment are requirements.

PREFERRED QUALIFICATIONS

• Six Sigma Black Belt certification preferred.
• Experience across multiple departments/functions is highly desired.
• Experience with AVI recipe development on Korber Seidenader equipment.

PHYSICAL/MENTAL REQUIREMENTS

• Gowning to access production floor will be required.
• Ability to troubleshoot complex automated systems is required.
• Mature project and presentation skills and financial and business acumen are required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel may be required for specific projects, training, or network support.
• Job may also require occasional weekend/evening work supporting a 24-hour/7-day operation.

OTHER JOB DETAILS

Last Date to Apply for Job: September 15, 2026. Referral Bonus Eligibility: YES Relocation support available Work Location Assignment: On Premise

The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program.

We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

• 401(k) plan with Pfizer Matching Contributions
• additional Pfizer Retirement Savings Contribution
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

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Manufacturing Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.