Senior Validation Specialist

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

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 also provide technical support for continuous improvement projects, driving the projects to completion to support the 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 that the program remains compliant with corporate, regulatory, and industry standards and regulations. The incumbent will develop strategies and updates to program documentation to resolve complex challenges to improve the validation program at the site level. The incumbent in this position will provide guidance for the execution of validation activities, collaborating with the SME(s) of the site Quality Assurance Validation group, resolving deviations to resolve complex deviations and identify appropriate strategies for validation activities.
The incumbent will exercise own expertise to work independently with instruction on complex problems.

The Senior Validation Specialist 1 is expected to utilize their own subject matter expertise, as well as 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.

• 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, utilizing industry knowledge 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], for appropriateness, completeness and alignment with quality, validation and regulatory expectation, providing sounds quality and compliance judgment to ensure meeting Pfizer Quality Standards, 21
  
  CFRpart
  11, ICH, MHRA, WHO guidance
• Supporting internal and external audits
• Providing technical support and fully implement change controls and commitments, including regulatory commitments and change controls with regulatory impact

• Applicant must have a 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) and 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 required
• Strong knowledge of other validation disciplines, GMP and regulatory requirements, and data integrity principles
• Demonstrated leadership, management, and technical capabilities
• Proven…