Process Validation Manager
Process Validation Manager
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Job Description
Use Your Power for Purpose
At Pfizer everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture rooted in science and risk-based compliance is both flexible and innovative always putting the customer first. Whether your role involves development maintenance compliance or analysis through research programs your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.
What You Will Achieve
In this role you will:
Provide process validation troubleshooting support for all equipment/unit operations and processes on site related to Sanfords Vaccine or other products.
Lead and/or participates in the planning preparation and execution of process validations including continued process verification as well as supporting tech transfer activities and related projects. This includes generation of protocols and cleaning assessments direct sampling of equipment working with manufacturing to align sample schedules understanding Delta V controls and pulling data from LIMs.
Lead or co-lead moderately complex projects managing time and resources effectively while providing guidance
Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems
Operate independently in ambiguous situations determining objectives of assignments and seeking directional review when necessary
Review your own work and potentially mentor others exercising judgment and becoming a resource for colleagues
Guide operational teams in project management resource forecasting and identifying areas for improvement in products processes or services
Facilitate agreements between teams to achieve project goals and coordinate validation/qualification work including plans strategies and risk assessments
Review and approve change controls ensuring validation impact assessments and appropriate testing to maintain validated states
Collaborate with Operations Quality Technical groups and other site/network groups to meet business and compliance requirements
Think through issues and troubleshoot problems related to cleaning and processing work with the investigations group to provide technical justifications understanding changes to cleaning and process systems and interact with regulatory authorities during audits.
Provide technical support participate in change control implementations deliver validation training and ensure compliance with company policies and government regulations
Here Is What You Need (Minimum Requirements)
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.Strong understanding of validation principles and practices
Experience with FDA and EU regulatory requirements and guidelines for validation
Experience with technical transfers
Proficiency in project management and resource planning
Ability to work independently and make decisions in ambiguous situations
Excellent communication and interpersonal skills
Proficiency in computerized systems and software applications
Bonus Points If You Have (Preferred Requirements)
Demonstrated process and/or cleaning validation experience in a biopharmaceutical/harmaceutical GMP environment
Additional experience in other areas of validation
PHYSICAL/MENTAL REQUIREMENTS
Position requirements are typical for an office-based work environment. There are no unusual physical or mental requirements for this position.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Schedule is primarily day shift but may require off-shift work on occasions. The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.
OTHER JOB DETAILS
Last Date to Apply for Job: July 28 2025.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
Relocation support available
Work Location Assignment:On Premise
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
