Sr Process Engineer

Pfizer

7d • Onsite

About The Position

Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve In this role, you will: Conducts tests and measurements throughout stages of production to determine control over applicable variables. Investigates deviations of high complexity, involving multiple departments, with significant scope that occur on the manufacturing floor. Performs root-cause analysis utilizing 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 and divisional 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 may use 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. Participates in developing compliance gap assessments and responses for Pfizer Quality Standards or for Regulatory Observation Network Assessments. Contributes to master planning exercises by maintaining matrices of unit capabilities, gaps, and needs. Participates in network or industry communities of practice to evaluate emerging technologies and best practices. May serve as a key site technical SME for specific unit operations or technologies.

Requirements

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Strong understanding of cGMP and regulatory requirements
• Proficiency in troubleshooting and problem-solving within a manufacturing environment
• Excellent communication and organizational skills
• Ability to work independently and as part of a team
• Experience with process validation and documentation
• Familiarity with environmental, health, and safety standards

Nice To Haves

• Experience in a pharmaceutical manufacturing environment
• Knowledge of Lean Manufacturing principles
• Proficiency in data analysis and statistical tools
• Strong project management skills
• Ability to mentor and train junior colleagues
• Experience with regulatory inspections and audits
• Strong attention to detail and commitment to quality
• Ability to adapt to changing priorities and work in a fast-paced environment
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Conducts tests and measurements throughout stages of production to determine control over applicable variables.
• Investigates deviations of high complexity, involving multiple departments, with significant scope that occur on the manufacturing floor.
• Performs root-cause analysis utilizing 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 and divisional 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 may use 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.
• Participates in developing compliance gap assessments and responses for Pfizer Quality Standards or for Regulatory Observation Network Assessments.
• Contributes to master planning exercises by maintaining matrices of unit capabilities, gaps, and needs.
• Participates in network or industry communities of practice to evaluate emerging technologies and best practices.
• May serve as a key site technical SME for specific unit operations or technologies.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees