Manager, Process Engineering - Sterile Inspection

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

Manager, Process Engineering - Sterile Inspection

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

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 as 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

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. 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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Manufacturing

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 as 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.