Sr. Validation Associate (Secondment - 6 Months)

Pfizer•Sanford, NC

11h•Hybrid

About The Position

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.

Requirements

Applicant must have a 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 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.
Permanent work authorization in the United States.

Nice To Haves

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 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.

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.