Sr. Validation Associate (Secondment - 6 Months)
Hybrid · Sanford, North Carolina, United States
Job Summary
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.
Required Qualifications
- Bachelor's degree with at least 2+ years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6+ years of experience; OR a high school diploma (or equivalent) and 8+ years of relevant experience.
- Proven expertise in Good Manufacturing Practices.
- Strong working knowledge of quality systems and processes.
- Familiarity with information systems such as Global Document Management System, SAP (SAPS), and Quality Tracking System.
- Excellent verbal and written communication skills.
- Ability to work independently and in a team environment.
- Experience with regulatory audits and compliance.
- Experience using AI tools, including generative technologies to support problem solving and productivity (e.g., ChatGPT, Microsoft Copilot).
- May require weekend or after-hours work.
Additional Requirements
- Candidates must be authorized to be employed in the U.S. by any employer.
- U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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