Validation and Compliance Specialist- GMP/Pharma Industry

Pfizer Inc; United States; On-site; USD 69,000 - 114,000; Full time

Job summary

Pfizer Inc. is seeking a Validation professional to author, review, and approve validation master plans, protocols, and reports in line with GMP and VMP requirements.

You will contribute to projects, manage time, and coordinate testing with various functional groups while maintaining the Site Validation Master Plan and supporting audits and regulatory inquiries.

Qualifications

• Requires GMP expertise and strong knowledge of quality systems.
• Experience with regulatory audits and compliance is preferred.
• Excellent verbal and written communication, ability to work independently and in a team.

Responsibilities

• Author/Review/Approve validation master plans, protocols, and reports.
• Perform validation activities per GMP and VMP requirements.
• Coordinate testing with functional groups and maintain the Site Validation Master Plan.
• Support regulatory queries and audits; assist with deviation investigations.

Skills

GMP expertise

Quality systems

Communication skills

Teamwork

Mentoring

Education

High school diploma + 8+ years

Associate's degree + 6+ years

BS + 2+ years

Tools

Global Document Management System

SAP

Quality Tracking System

Veeva

Kneat

AI tools (e.g., ChatGPT, Copilot)

Job description

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.

What You Will Achieve

• Author, review, and /or approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
• Perform a variety of 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 such as Supplier Quality Management, Change Control, Quality Risk Management, Documentation, and Investigations, Annual Product Review and coordinate testing with functional groups.
• Maintain the Site Validation Master Plan and support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility
• Support 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)

• High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BS with at least 2+ years of experience in pharmaceutical industry
• Proven expertise in Good Manufacturing Practices
• Strong working knowledge of various 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

Bonus Points If You Have (Preferred Requirements)

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
• Experience with quality management systems like Veeva and Kneat
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to mentor and guide other 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. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
• Technical writing skills

Physical/Mental Requirements

• Ability to perform mathematical calculations and ability to perform complex data analysis.
• Sitting, lifting, standing and bending.

Non-Standard Work Schedule, Travel, or Environment Requirements

• Minimal travel requirements (less than 5%) are expected.
• Position requires regular onsite attendance; this position cannot be performed on a remote / telecommute basis.

Other Job Details

Last day to apply: November 17th, 2026.

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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 any location outside of the United States.

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 provider's 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 lic