What You Will Achieve

Reporting to Site Technical Services Lead, this position is responsible for leading the site Validation organization supporting a continuous 24/7 aseptic manufacturing operations. The incumbent will provide strategic and operational leadership for teams responsible for Process Validation, Cleaning Validation, Aseptic Process Simulations (APS/media fills), Aseptic Process and Equipment Qualifications, Utility Qualifications, Facility and CTU qualifications, Smoke Studies, and Periodic Requalification programs.

 

This role serves as the site Subject Matter Expert (SME) for Validation and Qualification programs and is the principal point of contact for regulatory agency interactions related to validation strategy, execution, and lifecycle management.

 

The Senior Manager, Validation is accountable for building, developing, and leading a large, diverse organization of engineering professionals and managers responsible for the development, implementation, and maintenance of compliant validation systems that support safe, reliable, and compliant commercial supply.

Where appropriate, this role advises site leadership and operational teams on validation strategy, implementation of changes, and lifecycle management expectations, and provides training, tools, and governance to ensure sustained compliance and inspection readiness.

 

Accountable for activities involved in the evaluation, review and approval of the validation master plan, validation protocols and reports and typically includes developing and evaluating quality process and system standards to ensure compliance with company standards and governmental regulatory requirements, investigating/troubleshooting validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies, and writing, reviewing, approving and/or implementing documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.

How You Will Achieve It

Provide strategic leadership and oversight for all site validation and qualification activities, including:

o   Process Validation and Continued Process Verification

o   Cleaning Validation

o   Aseptic Process Simulations

o   Equipment Qualification

o   Utility Qualification

o   Facility and CTU qualification

o   Smoke Studies and airflow visualization

o   Periodic Review and Requalification programs

·       Serve as the site SME for Validation, leading regulatory interactions and representing site validation programs during FDA and global regulatory inspections.

·       Lead and manage a large, technically diverse organization of validation engineers, managers, and contractors; establish clear expectations, provide coaching and development, and build a strong culture of ownership, engagement, and accountability.

·       Establish and maintain robust validation lifecycle strategies, ensuring alignment with global PQS expectations, regulatory requirements, and industry best practices.

·       Provide governance and oversight for capital improvement projects, new installations, and process changes requiring qualification and/or validation.

·       Ensure validation activities are appropriately risk-based and aligned with regulatory expectations, including aseptic processing requirements and Annex 1 principles.

·       Partner closely with Operations, Engineering, Technical Services, Quality Compliance, Regulatory Affairs, and Automation to ensure integrated execution of validation activities.

·       Advise site leadership on evolving regulatory expectations, network standards, and industry trends impacting validation and aseptic processing.

·       Ensure validation documentation, data integrity, and lifecycle management practices support sustained inspection readiness

Here Is What You Need (Basic Requirements)

 

• Applicant must have bachelor's degree and 6+ years of relevant experience; OR a master's degree and 5+ years of relevant experience; OR a PHD with 1+ years of experience.

• Strong technical expertise in GMP validation and qualification within aseptic pharmaceutical manufacturing. Demonstrated expertise in aseptic processing validation, including APS/media fills, sterilization processes, and critical utility systems.

• Solid working knowledge of pharmaceutical quality systems, including deviations, investigations, change control, CAPA, and documentation systems. Minimum of 7+ years of relevant experience in pharmaceutical or biotechnology manufacturing. Prior experience working in an aseptic cGMP manufacturing environment with strong knowledge of validation lifecycle management.

 

Bonus Points If You Have (Preferred Requirements)

• In-depth understanding of global regulatory expectations for pharmaceutical validation, including Annex 1, FDA regulations, and other regulatory guidance.
• Demonstrated expertise in aseptic processing validation, including APS/media fills, sterilization processes, and critical utility systems.
• Ability to lead cross-functional governance forums and influence decision-making at all organizational levels.
• Minimum of 7+ years of relevant experience in pharmaceutical or biotechnology manufacturing.
• 5+ years of management or leadership experience in validation, qualification, quality, or compliance roles.
• Prior experience working in an aseptic cGMP manufacturing environment with strong knowledge of validation lifecycle management.
• Demonstrated strength in organizational leadership, project management, and balancing multiple priorities.
• Extensive experience interfacing with regulatory agencies and supporting regulatory inspections.
• Six Sigma or continuous improvement experience preferred
• Manage resources to meet organizational objectives, including workforce planning, performance management, coaching, succession planning, and colleague engagement.
• Understand site financial systems and manage departmental budgets responsibly.
• Champion site safety objectives and maintain a safe working environment, including adherence to 5S, ergonomics, and EHS expectations.
• Excellent written and verbal communication skills, with the ability to clearly communicate technical concepts to senior leadership and regulators.
• Strong analytical and problem-solving capabilities
• Experience using common AI tools

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
 

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform mathematical and statistical calculations and complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Responsible for technical support of a 24/7 aseptic manufacturing operation; position requires flexibility to support a two‑shift, 12‑hour operation as needed.

• Limited travel.

Work Location Assignment: Hybrid

Last Date To Apply: Jun 24, 2026

The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control