Manager, Process Engineering - Sterile Inspection

Pfizer • Kalamazoo, MI

5d • Onsite

About The Position

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.

Requirements

• 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.
• 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.
• Permanent work authorization in the United States.

Nice To Haves

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

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.

Benefits

• 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.
• Relocation support available
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager