Pfizer · 12 hours ago
Senior Validation Specialist 1
Andover, MA
Full-time
Onsite
Mid, Senior Level
4+ years expPfizer is a leading biopharmaceutical company, and they are seeking a Senior Validation Specialist 1 to support qualification activities for manufacturing processes and equipment. This role involves providing technical support for continuous improvement projects and ensuring compliance with corporate and regulatory standards.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
No H1B
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
Qualification
Required
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
Benefits
Participation in Pfizer’s Global Performance Plan with a bonus target of 12,5% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions
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
Company
Pfizer
Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$38BKey Investors
Starboard Value
2025-11-21Post Ipo Debt· $6B
2024-10-07Post Ipo Equity· $1B
2023-05-16Post Ipo Debt· $31B
Leadership Team
Albert Bourla
Chief Executive Officer
Ian Read
Chief Executive Officer
Recent News
2026-01-25
Pharma Letter
2026-01-25
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