Manager, Aseptic Engineering
Manager, Aseptic Engineering
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$ 112700 - 187800
1 Vacancy
Job Description
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 Pfizers 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 bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates 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 $112700.00 to $187800.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Required Experience:
Manager
Employment Type
Full-Time
