Senior Validation Specialist 1

Pfizer • Andover, MA

4d • Onsite

About The Position

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. The incumbent's responsibilities will 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, 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, 21CFRpart11, 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

Requirements

• 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 as 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 project management, analytical, and problem-solving skills
• Effective writing and oral communication skills and fluency in English

Responsibilities

• 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, 21CFRpart11, 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

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 12,5% of the base salary and eligibility to participate in our share based long term incentive program
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees