Senior Validation Engineer

Pfizer • Rochester, MI

1d • Onsite

About The Position

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. The Rochester Senior Validation Engineer is responsible for planning, scheduling, executing and leading various validation project assignments such as qualification, validation, and requalification activities related to manufacturing process, equipment, critical utility systems, product, cleaning, and/or sterilization processes. This role will also be responsible for the development/authoring of project plans, protocols, test scripts and reports throughout all life cycle of the process from initiation to continuous monitoring. The position will work closely with area owners and suppliers to finalize validation/qualification requirements for process, equipment and systems, ensuring that company policies, procedures, applicable regulations and guidelines are adhered to. This role will assist in troubleshooting, performing gap and risk assessments, provide support to regulatory inspections and conduct training as required.

Requirements

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Proven expertise in Good Manufacturing Practices
• Strong working knowledge of various quality systems and processes
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
• Excellent verbal and written communication skills
• Ability to work independently and in a team environment
• Must not have Penicillin allergy.
• Permanent work authorization in the United States.

Nice To Haves

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
• Experience with sterile products and medical devices
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to mentor and guide other colleagues
• Experience in regulatory audits and compliance
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Responsibilities

• Support the validation/qualification of manufacturing equipment, facility, combination product and critical utility systems.
• Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles
• Support the validation/qualification of laboratory equipment
• Develop/Author and execution of FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents
• Develop/Author validation master plans, SOPs, programs and policies, system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification
• Work cross functionally with multiple departments to schedule and complete all required activities
• Support corrective actions including investigating and resolving deviations as relevant to validation
• Support technical training on process and technology as required by the project
• Support audit preparation and defend areas of Validation responsibility
• Carryout process capability analysis on all commercial processes on a periodic basis. Identify areas for improvement where process capability is deemed to be unacceptable
• Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
• Review site change controls to ensure the validated state of a process is not impacted by a proposed change
• Lead the implementation of projects to reduce process risk, optimize plant and process productivity
• Will required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade D)
• Role will require after hour and weekend support from time to time

Benefits

• 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
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

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