Validation and Compliance Specialist- GMP/Pharma Industry

Pfizer • Franklin, OH

12h • Onsite

About The Position

Pfizer is seeking a Validation and Compliance Specialist to support quality and compliance in the pharmaceutical industry. The role contributes to delivery of safe and effective products by carrying out validation activities in accordance with Good Manufacturing Practices (GMP), the Validation Master Plan (VMP), company standards, and regulatory requirements. The specialist authors, reviews, and/or approves validation master plans, protocols, and reports; contributes to moderately complex projects; and plans and manages short-term work activities.

The position manages routine quality systems, including Supplier Quality Management, Change Control, Quality Risk Management, Documentation, Investigations, and Annual Product Review, while coordinating testing with functional groups. The specialist maintains the Site Validation Master Plan, serves as a validation subject matter expert during customer and regulatory audits, supports regulatory queries and cost-improvement projects, and helps ensure Cleaning Validation schedules are integrated with production. The role also participates in deviation investigations.

This is an onsite position that cannot be performed remotely or by telecommuting. Minimal travel of less than 5% is expected. The position requires permanent work authorization in the United States.

Requirements

• High school diploma or equivalent and 8 or more years of experience, an associate’s degree and 6 or more years of experience, or a bachelor of science degree and at least 2 years of experience in the pharmaceutical industry.
• Proven expertise in Good Manufacturing Practices.
• Strong working knowledge of quality systems and processes.
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.
• Excellent verbal and written communication skills.
• Ability to work independently and in a team environment.

Nice To Haves

• Strong technical knowledge of validation or qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
• Experience with quality management systems such as Veeva and Kneat.
• Strong analytical and problem-solving skills.
• Strong organizational and time-management skills.
• Ability to mentor and guide colleagues.
• Experience in regulatory audits and compliance.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem-solving and productivity.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• Technical writing skills.

Responsibilities

• Author, review, and/or approve validation master plans, protocols, and reports in compliance with company standards and regulatory requirements.
• Perform validation activities in accordance with GMP and VMP requirements.
• Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
• Manage routine quality systems, including Supplier Quality Management, Change Control, Quality Risk Management, Documentation, Investigations, and Annual Product Review.
• Coordinate testing with functional groups.
• Maintain the Site Validation Master Plan.
• Support validation as a subject matter expert during customer and regulatory audits in areas of responsibility.
• Support regulatory queries and cost-improvement projects.
• Support Cleaning Validation, including integrating validation schedules with production.
• Participate in deviation investigations.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver/parental and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 7.5% of base salary.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED