Validation Engineer I

Pfizer • Andover, MA

3d • Hybrid

About The Position

Our breakthroughs would not make it to the hands of patients without our validation team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. This role will provide validation support related to qualification of manufacturing processes and equipment used for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The validation engineer will assist in qualification activities including, but not limited to cleaning validation, equipment changeover, chamber qualification, sterilization qualification, steam quality testing, temperature mapping, and periodic review. As part of the Clinical Manufacturing Validation team, you will support GMP‑compliant validation activities for clinical manufacturing operations. Responsibilities include coordinating and executing validation deliverables, supporting IQ/OQ/PQ activities, managing validation schedules, and reviewing and completing validation documentation. You will work closely with Validation, Manufacturing, Quality, and SME partners to assess execution status, ensure timely completion of assigned activities, and respond to validation-related requests. Your technical rigor, attention to detail, and continuous improvement mindset will help ensure compliant, reliable clinical manufacturing processes and support the delivery of high‑quality medicines to patients worldwide.

Requirements

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
• Experience in a GMP biotechnology manufacturing or laboratory environment
• Ability to execute against Standard Operating Procedures and document entries in a compliant manner
• Demonstrated capability to work as a team member in a matrix development team
• Strong analytical and computer skills
• Excellent oral and written communication skills
• Ability to maintain a safe work environment
• Must be able to climb flights of stairs and be standing for ~1-2 hours at a time.
• Must be able to lift up to 25lb
• Must be able to complete gowning activities.
• Must be able to wear Personal Protective Equipment (PPE) to handle hazardous materials

Nice To Haves

• Experience working in a large-scale manufacturing facility
• Previous experience with cleaning validation and/or temperature mapping
• Experience with facility/equipment commissioning and qualification
• Familiarity with creating essential cGMP documentation
• Commitment to continuous improvement and operational excellence
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

Responsibilities

• Plan and coordinate the validation work assigned
• Gain technical understanding of process and equipment to be qualified
• Perform the work in accordance to all compliance requirements and in a safe manner.
• Perform temperature mapping of CTUs: Incubators, Refrigerators, Freezers, and Environmental Rooms
• Sample various process equipment in support of the cleaning program (product changeover, cleaning monitoring, performance qualification)
• Support validation of chambers: Autoclaves, Glasswashers, etc.
• Perform periodic reviews of qualified equipment ensuring that the equipment is maintained in a validated state
• Enhance cleaning program by performing bench scale cleaning studies of incoming process soils to establish carryover limits and HBELs

Benefits

• In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

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