Senior QA Validation Associate

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

What You Will Achieve

In this role, you will:

• Review validation documentation for the site, (including but not limited to change controls, cleaning, process, equipment, laboratory validation, data records, SOPs, automation and maintenance document, and technical reports associated with clinical and commercial processing) ensuring adherence to regulatory agency requirements, ICH Guidelines, and Pfizer standards, policies and values

• Plan and execute projects with support; suggest improvements and conducts continuous improvement activities

• Represent QA Validation in cross-departmental/cross-site meetings

• Maintain oversight of quality and compliance requirements throughout the product life cycle from design through BLA submission

• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.

• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.

• Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.

• Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.

• Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Here Is What You Need (Minimum Requirements)

•  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.

• Proven expertise in current Good Manufacturing Practices and relevant GxP regulations and standards.

• Experience with regulatory compliance and documentation

• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System

• Strong working knowledge in Microsoft Office Suite

Bonus Points If You Have (Preferred Requirements)

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems

• Experience in regulatory audits and compliance

• Experience with sterile products and medical devices

Physical/Mental Requirements

• Excellent verbal and written communication skills

• Ability to work independently and in a team environment

• Strong analytical and problem-solving skills

• Strong organizational and time management skills

• Ability to mentor and guide other colleagues

Non-Standard Work Schedule, Travel, or Environment Requirements

• This role is standard day Monday through Friday work shift.

Other Job Details:

• Last day to Apply: October 13th, 2025

• Eligible for Relocation Assistance: No

• Work Location Assignment: On Premise

The annual base salary for this position ranges from $80 300,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary. 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 a