Validation and Compliance Specialist- GMP/Pharma Industry

Pfizer Inc; Franklin (OH); Sur place; USD 69 000 - 114 000; Plein temps

Avantages offerts par ce poste

401(k) matching

Comprehensive health benefits

Paid vacation and holidays

Résumé du poste

Pfizer Inc. is seeking a Validation/Quality professional to author and review validation master plans and reports, ensuring GMP compliance. You will execute validation activities, support audits, and coordinate with cross-functional teams on quality systems and regulatory inquiries.

The role requires strong communication, ability to work both independently and in a team, and experience with GMP, VMP, and quality management systems. Onsite with minimal travel, comprehensive benefits offered.

Qualifications

• Experience with GMP and regulatory compliance is required.
• Knowledge of quality systems and processes across operations.
• Strong written and verbal communication skills.
• Ability to work independently and in a team environment.
• Experience with quality management systems like Veeva and Kneat is a plus.
• Ability to mentor and guide colleagues during audits.

Responsabilités

• Author, review, and/or approve validation master plans, protocols, and reports following company standards.
• Perform validation activities in GMP and VMP compliance.
• Contribute to moderately complex projects and develop short-term work plans.
• Manage routine Quality systems including Supplier Quality Management, Change Control, Quality Risk Management, Documentation, Investigations, and Annual Product Reviews.
• Maintain the Site Validation Master Plan and support audits as SME.
• Support regulatory queries, cost improvement projects, and Cleaning Validation.

Connaissances

Good Manufacturing Practices

Quality systems knowledge

Verbal and written communication

Independent and team work

Regulatory audits

Problem solving

Time management

Formation

High school diploma + 8+ years experience

Associate’s degree + 6+ years

Bachelor’s degree + 2+ years

Outils

Global Document Management System

SAP (System Applications & Products)

Quality Tracking System

Description du poste

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 licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.