Manager, Process Engineering - Sterile Inspection

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,…