Description
At Pfizer, you will evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.
Responsibilities:
- Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
- Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
- Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
- Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
- Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
- Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
- Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.
Requirements:
- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
- 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
Preferred Qualifications:
- Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
- Experience with sterile products and medical devices
- 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 Microsoft Copilot, to support problem solving and enhance productivity.
Additional Information:
- Working hours: 7 am - 3:30 pm
- Annual base salary: $82,700.00 to $137,900.00
- Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary
- Comprehensive benefits and programs, including 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