Validation and Compliance Specialist- GMP/Pharma Industry
About The Position
The Validation and Compliance Specialist supports quality and validation activities in the pharmaceutical industry, ensuring that work complies with Good Manufacturing Practices (GMP), the Site Validation Master Plan (VMP), company standards, and regulatory requirements. The role authors, reviews, and/or approves validation master plans, protocols, and reports, and contributes to moderately complex projects while planning 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, coordinating testing with functional groups. It maintains the Site Validation Master Plan and serves as a validation subject matter expert during customer and regulatory audits. The specialist also supports regulatory queries, cost improvement projects, 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 with at least 8 years of experience, an associate’s degree with at least 6 years of experience, or a bachelor of science degree with 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.
- Permanent work authorization in the United States.
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 enhance productivity; curiosity about improving outcomes with these tools 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 compliance 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 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.
- Eligibility for 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
