Manager, Aseptic Engineering

What You Will Achieve

The Manager, Aseptic Engineering provides Center of Excellence and direct support for aseptic requirements within each Focus Factory. This role ensures alignment with global and industry aseptic practices and leads the implementation of critical programs that uphold product sterility, regulatory compliance, and operational excellence. The position plays a key role in driving aseptic process engineering, validation, and training initiatives while supporting capital projects and continuous improvement efforts across the site.

This role will report into the Director, Site Technology and Launch and will also provide direct support to each Focus Factory, as needed. 

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them. 

How You Will Achieve It

• Lead the development and execution of aseptic engineering strategies aligned with global and industry standards, ensuring robust support for Focus Factory operations.
• Oversee the Qualification & Validation Program for aseptic processes, ensuring compliance with regulatory expectations and internal quality standards.
• Manage the Aseptic Process Engineering Program, including the design, optimization, and troubleshooting of aseptic manufacturing systems, including the design and assessment of Aseptic Interventions.
• Direct the Airflow Visualization Program and Aseptic Simulation Program (e.g., smoke studies and media fills) to validate cleanroom performance and aseptic operator practices.
• Develop and implement regulatory filing strategies for aseptic-related activities in collaboration with Regulatory Affairs.
• Ensure PQS (Pfizer Quality Standards) and global standard implementation and monitoring across aseptic operations.
• Serve as the Local Process Owner (LPO) for revolutionized programs related to aseptic practices.
• Lead change management initiatives for aseptic processes, ensuring structured and compliant transitions.
• Provide coaching and training to Focus Factory teams on aseptic techniques, behaviors, and compliance expectations.
• Support complex investigations related to aseptic deviations, contamination events, or process failures.
• Collaborate with Focus Factory Manufacturing Technology Teams to integrate aseptic engineering into daily operations and project execution.
• Contribute to capital project planning and execution, including the Site Capital Plan, Site Master Plan, and ST&L Budget.
• Participate in project selection and prioritization, and oversee the execution of project plans for Focus Factory aseptic initiatives.
• Promote a mature Focus Factory model that fosters autonomy in technical decision-making and a self-sustaining work structure.
• Manage departmental budgets, track aseptic project milestones, and ensure timely completion of CAPAs (Corrective and Preventive Actions) and change controls.

Here Is What You Need (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 

Bonus Points If You Have (Preferred Qualifications)

• Experience in aseptic process engineering, validation, or manufacturing leadership within a regulated pharmaceutical environment
• Experience with Airflow Visualization and Aseptic Simulation concepts and strategies
• Demonstrated success in leading cross-functional teams and aseptic capital projects
• Relevant certifications such as Six Sigma, Lean Manufacturing, or PMP
• Familiarity with Pfizer systems, global quality standards, and regulatory expectations related to aseptic operations
• Strong understanding of PQS implementation, regulatory filing strategies, and contamination control practices

  
 

PHYSICAL/MENTAL REQUIREMENTS

• Ability to manage multiple complex projects simultaneously in a dynamic manufacturing environment
• Strong analytical and problem-solving skills to support technical investigations and decision-making
• Capacity to work in and around manufacturing areas, which may require standing, walking, or occasional lifting
• Mental focus and resilience to handle high-stakes technical challenges and cross-functional collaboration
• Ability to interpret and apply technical standards, regulatory expectations, and validation protocols

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Flexibility to support off-shift or weekend work during critical phases of technical projects or shutdowns
• Occasional travel may be required to support cross-site initiatives, vendor engagements, or regulatory inspection
• Ability to work in manufacturing environments, including classified areas, which may require adherence to aseptic gowning procedures and other safety protocols
• Willingness to be on-site during key validation, commissioning, or troubleshooting activities that may occur outside standard business hours

Work Location Assignment: On Premise

Last Date To Apply: June 27, 2025

The annual base salary for this position ranges from $112,700.00 to $187,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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.

Engineering