Senior Validation Specialist

Overview

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

The Senior Validation Specialist 1 will support a diverse variety of qualification activities for manufacturing processes and equipment within a biopharmaceutical manufacturing facility, including shipping validation, equipment qualification, steaming and depyrogenation qualification.

This role will provide technical support for continuous improvement projects, driving projects to completion to support ongoing activities within a manufacturing environment. As a Senior Validation Specialist 1, you will act as a subject matter expert / program owner within the team, ensuring the program remains compliant with corporate, regulatory, and industry standards and regulations. You will develop strategies and updates to program documentation to resolve complex challenges to improve the validation program at the site level.

You will provide guidance for the execution of validation activities, collaborating with the site Quality Assurance Validation group SMEs, resolving deviations and identifying appropriate strategies for validation activities. You will exercise expertise to work independently with instruction on complex problems.

The Senior Validation Specialist 1 will utilize their own subject matter expertise, and collaborate with other site validation SMEs, to define, standardize and support the Steaming, Equipment, and Shipping validation programs and procedures in compliance with corporate, regulatory, and industry standards and regulations.

The incumbent’s responsibilities include, but are not limited to, the following:

• Providing support for the validation program and validation projects at the Pfizer Andover site
• Applying comprehensive technical knowledge and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs, to drive programmatic updates to maintain compliance
• Authoring, reviewing, and approving routine to highly complex validation deliverables (Validation Plan, Validation Strategy, Requirements Specification, Qualification Protocols (IQ, OQ, PQ), Change Control Implementation Plans and Impact/Risk Assessment, deviations, investigations, corrective actions and/or preventive actions) for adequacy, logic and quality/validation/regulatory impact
• Supporting internal and external audits
• Providing technical support and fully implementing change controls and commitments, including regulatory commitments and change controls with regulatory impact

• Bachelor’s degree with at least 4 years of experience; OR a Master’s degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate’s degree with 8 years of experience; OR a high school diploma (or equivalent) with 10 years of relevant experience
• Experience with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)
• Comprehensive understanding of equipment/steaming/shipping validation experience
• Strong knowledge of other validation disciplines, GMP and regulatory requirements, and data integrity principles
• Demonstrated leadership, management, and technical capabilities
• Proven project management, analytical, and problem-solving skills
• Effective writing and oral communication skills and fluency in English

Normal sitting, standing and walking requirements to facilities and in a laboratory environment. Position is first shift Monday through Friday with possible off-hour support to assist staff and operations.

• Last day to apply:
  February 2nd
• Work Location Assignment:
  On Premise
• Relocation assistance may be available based on business needs and/or eligibility

The annual base salary ranges from…