Manager, Process Engineering - Sterile Inspection

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.

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.

• 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.

• 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.

• Six Sigma Black Belt…