WHAT YOU WILL ACHIEVE:
In this role, you will lead the Middleton Site validation team, including colleagues and contractors, to deliver compliant, effective, and sustainable validation programs. You will enable successful execution of cleaning, equipment, and process validations, periodic validation reviews, and continuous improvement initiatives that support site operations and regulatory readiness. As the site validation subject matter expert, you will partner closely with Site Leadership, Quality, Engineering, Production, and network stakeholders to identify, prioritize, and implement improvements that strengthen validation capabilities and drive long‑term site performance.
ROLE SUMMARY:
In this role, you are responsible for leading and sustaining robust validation and cleaning programs at the Middleton site. You serve as the site validation subject matter expert, providing both technical and strategic oversight to ensure all validation activities are executed in full compliance with cGMP requirements, internal SOPs, and site Validation Master Plans. Leveraging your deep expertise in validation and strong understanding of related disciplines, you will maintain the facility’s Validation Master Plans, guide complex cross‑functional initiatives, and ensure validation strategies align with regulatory expectations and organizational objectives.
You operate with a high degree of autonomy, setting direction and priorities for a team of validation professionals while fostering accountability, engagement, and continuous improvement. As a visible leader, you will collaborate with senior internal and external stakeholders, represent the validation team in technical and regulatory discussions, and drive innovation in the Middleton site’s validation programs to support both current operations and future growth.
ROLE RESPONSIBILITIES:
Lead site‑level validation and cleaning programs by applying technical expertise in validation disciplines, industry standards, and cGMP requirements to ensure compliant execution of defined processes.
Develop, maintain, and implement the site Validation Master Plans in alignment with regulatory expectations, internal standards, and operational needs.
Provide clear goals, priorities, and direction for validation colleagues and contractors, ensuring validation activities are executed in accordance with SOPs, Validation Master Plans, and quality system requirements.
Serve as the Middleton Site validation subject matter expert, maintaining strong working knowledge of related disciplines and collaborating cross‑functionally to support integrated and compliant outcomes.
Resolve complex validation and operational challenges by gathering and analyzing information from multiple sources, identifying root causes, and implementing practical, compliant solutions aligned with site and organizational objectives.
Plan, manage, and coordinate multiple validation projects and ongoing work activities of moderate complexity, ensuring delivery against timelines, resource plans, and budget expectations.
Sustain and continuously improve the Middleton Site validation programs by identifying opportunities to strengthen processes, documentation, and execution effectiveness.
Lead, coach, and develop validation team members by fostering engagement, accountability, and effective collaboration while supporting appropriate independence in day‑to‑day assignments.
Partner closely with Site Leadership, Quality, Engineering, Production, and network stakeholders to support validation planning, execution, and continuous improvement initiatives.
Represent the site in internal and external technical discussions, including audits, briefings, and meetings related to validation and qualification requirements
BASIC QUALIFICATIONS:
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
Manufacturing experience in a pharmaceutical GMP environment
Language Skills: Effective written and oral communication
Computer Skills: Microsoft Applications
Project execution: History of delivering on project deliverables and experience in leading significant investigations and/or site-wide initiatives or program changes.
Mentoring: Demonstrated mentoring and training of other colleagues.
PREFERRED QUALIFICATIONS:
Demonstrated previous supervisory management experience in problem solving, decision making, negotiating and conflict resolution skills
In depth knowledge and experience with investigations and compliance-related procedures
Green Belt certified
PHYSICAL/MENTAL REQUIREMENTS:
Physical Demands: Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.
Work Environment: Office environment, with frequent time in manufacturing.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Colleague must be willing to work off-hours when project or production demands require it.
Minimal travel requirements
OTHER JOB DETAILS
Last Date to Apply for Job: March 24, 2026.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: Yes
Work Location Assignment: On Premise
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.
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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.
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