QA Validation Specialist III

Pfizer • Andover, MA

3d • $82,700 - $137,900 • Onsite

About The Position

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.

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
• Strong understanding of validation principles and practices
• Experience with regulatory requirements and guidelines for validation
• Proficiency in project management and resource planning
• Ability to work independently and make decisions in ambiguous situations
• Excellent communication and interpersonal skills
• Proficiency in computerized systems and software applications
• Permanent work authorization in the United States.

Nice To Haves

• Comprehensive knowledge of GMP regulations and guidance, including 21 CFR Parts 11, 210 & 211, EC Annex 15, and ICH 7
• Strong background in problem-solving, negotiations, and data integrity principles
• Experience in project management/support within a matrixed reporting environment
• Good understanding of risk management methodologies and their application to Bio-pharmaceutical operations
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance daily work and organization.
• Technical writing experience
• Proven relevant industry experience in either Quality Assurance or Validation engineering.
• Combined experience in Quality Assurance or Validation Engineering / Engineering / Manufacturing / Laboratories preferred.

Responsibilities

• Serve as Quality Assurance oversight for the validation program at the Andover, MA Pfizer site.
• Primary focus on validation documentation review and approval including specifications, protocols, other testing documents, summary reports, higher level validation plans, program documentation and strategies.
• Review and approval of change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
• Provide support to project teams on compliance and technical issues related to validation to ensure compliance with company policies and government regulations.
• Review and approve investigations, commitments, and procedures, and maintenance work orders as they relate to validation.
• Exercises judgement in resolving simple to moderate quality validation issues.
• Participate in continuous improvement initiatives.
• Maintain a constant state is inspection readiness.
• Skilled in the use of Enterprise systems including, but not limited to Veeva (eQMS), Pfizer Document Repositories, Pfizer Equipment Maintenance System

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level