Validation and Compliance Specialist- GMP/Pharma Industry

Pfizer • Franklin, OH

6d • Onsite

About The Position

The Validation and Compliance Specialist supports quality and compliance activities in the pharmaceutical industry, helping ensure the delivery of safe and effective products. The role performs validation work in accordance with Good Manufacturing Practices (GMP), the site Validation Master Plan (VMP), company standards, and regulatory requirements.

The specialist authors, reviews, and approves validation master plans, protocols, and reports; maintains the Site Validation Master Plan; and serves as a validation subject matter expert during customer and regulatory audits. The role also manages routine quality systems and coordinates testing with functional groups, supports regulatory queries and cost improvement projects, and contributes to Cleaning Validation, production-integrated validation scheduling, and deviation investigations.

This position requires regular onsite attendance and cannot be performed remotely. Minimal travel of less than 5% is expected.

Requirements

• High school diploma or equivalent and 8+ years of experience, an associate’s degree and 6+ 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.
• Ability to perform mathematical calculations and complex data analysis.
• Ability to sit, lift, stand, and bend.
• Candidates must be authorized to work in the United States by any employer; U.S. work visa sponsorship is not available.
• Permanent work authorization in the United States is required.

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 accordance with company standards and regulatory requirements.
• Perform validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan (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 for areas of responsibility.
• Support regulatory queries and cost improvement projects.
• Support Cleaning Validation and integrate validation schedules into production.
• Participate in deviation investigations.

Benefits

• 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.
• Medical, prescription drug, dental, and vision coverage.
• Eligible 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