WHY PATIENTS NEED YOU
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always oriented towards the customer. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients.
WHAT YOU WILL ACHIEVE
Reporting to the Sr. Manager, the Validation Manager will lead a team of validation technical experts and engineers to assure that manufacturing equipment and processes are validated and maintained in accordance with GxP principles, regulatory requirements, and Pfizer policies and standards. This role provides expertise and is an SME in the initial qualification, requalification and continuous compliance of the entirety of the sites aseptic equipment requalification and is critical in the sites ability to maintain GMP compliance with a responsibility to assure that all assigned aseptic and non-aseptic equipment is in compliance with GxP.
HOW YOU WILL ACHIEVE IT
Lead and guide a team of Validation Specialists in planning and executing validation activities - Equipment qualifications and requalification.
Coordinate with various stakeholders to identify and meet requirements for compliant qualifications and requalification.
Ensure aseptic equipment are in place to meet or exceed site operation and compliance requirements.
Provide leadership in developing validation strategies and master plans for various equipment and processes for qualifications and requalification.
Maintain and manage validation documents throughout project phases including documentations and updates for EDES (Kneat) continuation.
Review, approve and author qualification documents, SOPs and batch records as applicable.
Support assessing change request for qualifications impact and propose an action plan.
Development, coordination and execution of process changes, change requests, protocols and document revisions as required to meet regulatory and cGMP requirements.
Ensure the site’s aseptic equipment are qualified and maintained to GxP compliance.
Routinely interface with global regulatory agencies, Pfizer Centre One Customers, and above-site PGS leadership providing technical expertise on capital and CI projects.
Plans and oversees the execution of requalification and initial qualification activities following applicable regulatory and Pfizer guidance.
Implements department strategy, by leading cross functional projects in the design or redesign of projects.
Author, Review, and approve validation lifecycle documents such as: VPP, URS, SIA, ERES, IQ, OQ, PQ, TM required to comply with FDA regulations, EU regulations, and other regulatory agencies as applicable
Inspire colleagues to embrace change and motivate them to continuously improve keeping up with changing external regulatory environment.
Build strong collaborative relationships with site leader, site PMO and OpEx teams, site colleagues, and Pfizer Global Supply groups (center functions, other sites) necessary to drive and implement needed changes and improvements.
QUALIFICATIONS
Must-Have
Applicant must have a bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 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.
Strong People Management skills.
Extensive experience in engaging with regulatory and third-party representatives.
Excellent organizational, presentation, meeting facilitation, project/time management, and technical writing skills.
Proficiency in developing validation strategies and master plans.
Ability to manage multiple projects and ongoing work activities within the department.
Strong analytical and problem-solving abilities.
Nice-to-Have
A deep understanding and comprehensive knowledge of regulatory requirements and validation processes as they apply to pharmaceutical equipment and facilities.
Experience in leading cross-functional teams.
Ability to develop and implement innovative solutions.
Proficiency in risk management and compliance strategies.
PHYSICAL/MENTAL REQUIREMENTS
Requires routine sitting, standing, walking, listening and talking.
Acute mental and visual attention at all times.
Handle multiple projects while managing frequent interruptions.
Requires moderate lifting or moving up to 25 pounds (lbs).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Requires regular onsite attendance.
Must have the ability to work effectively under strict deadlines.
Must be able and willing to work beyond office hours which may include weekends and holidays.
Must be capable of supporting up to 10% travel (domestic and international).
OTHER JOB DETAILS
Last Date to Apply for Job: December 11, 2025
Additional Location Information: NO
Eligible for Relocation Package – NO
Secondment 12 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
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 provider’s 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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.