Job Overview In this role, you will author, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.

Key Responsibilities

• Perform various 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.
• Support 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 BS with at least 2+ years of experience in the 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.

Preferred Qualifications

• 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.
• Technical writing skills.

Physical and Mental Requirements

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

Work Schedule and Travel

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

Compensation and Benefits

• The annual base salary for this position ranges from $68,600.00 to $114,300.00.
• Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.
• Comprehensive and generous benefits and programs, including a 401(k) plan with Pfizer Matching Contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits.

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