Senior Validation Engineer

Pfizer • McPherson, KS

3d • $82,700 - $137,900 • Onsite

About The Position

The Senior Validation Engineer leads complex validation projects and supports quality investigations, troubleshooting, and site compliance. The role ensures validation and qualification activities meet current Pfizer standards and applicable cGMP and GxP requirements. It serves as a point-of-contact subject matter expert for routine quality systems, including change control, quality agreements, documentation, submission authoring, and investigations.

The engineer authors or approves validation protocols and final reports, executes validations on the production floor, coordinates testing with affected functional groups, and evaluates results. The role maintains the Site Validation Master Plan and supports regulatory audits involving sterility assurance equipment, capital project qualifications, computerized systems, process validation, and cleaning validation. It also assesses the impact of changes to qualified systems, resolves technical issues, and improves site validation practices.

The role supports product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant validation needs. It integrates validation schedules with production schedules and conducts or participates in validation deviations and investigations to identify root causes and establish corrective or preventive actions. Regular onsite attendance is required, with travel up to 10% and occasional work beyond office hours, including weekends and holidays.

Requirements

• Bachelor's degree and at least 2 years of experience; or master's degree and more than 0 years of experience; or associate's degree and 6 years of experience; or high school diploma or equivalent and 8 years of relevant experience.
• Strong understanding of cGMPs, ISPE, data integrity, 21 CFR Part 11, industry good practices for IQ/OQ/PQ, and Standard Operating Procedures.
• Ability to work independently with limited managerial oversight.
• Strong verbal and written communication skills.
• Ability to work effectively under strict deadlines.
• Ability and willingness to work beyond office hours, including weekends and holidays.
• Ability to support up to 10% domestic and international travel.
• Must be authorized to work in the United States; U.S. work visa sponsorship is not available.
• Requires permanent work authorization in the United States.

Nice To Haves

• 5 or more years of direct validation experience in at least one field: equipment qualifications, computerized systems validation (CSV), aseptic validations, process validations, or cleaning validations.
• Strong technical knowledge and experience with validation or qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems related to sterile products and medical devices.
• Exposure to multiple validation workstreams.

Responsibilities

• Lead assigned complex projects, meet agreed targets, and develop plans for project work activities within a team.
• Provide high-level data analysis support for quality investigations and troubleshooting.
• Ensure compliance with current Pfizer standards for validation and qualification activities and applicable cGMP/GxP requirements.
• Serve as a point-of-contact subject matter expert for routine quality systems, including change control, quality agreements, documentation, submission authoring, and investigations.
• Author or approve validation protocols and final reports, and perform validation executions on the production floor.
• Coordinate testing with affected functional groups and evaluate test results.
• Maintain the Site Validation Master Plan.
• Support regulatory audits in areas including sterility assurance equipment, capital project qualifications, computerized systems, process validation, and cleaning validation.
• Provide expertise in troubleshooting and resolving validation-related issues in assigned areas.
• Assess the potential impact of changes to qualified systems.
• Identify and implement validation best practices to continuously improve the site validation program.
• Lead and support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant validation support.
• Integrate validation schedules into production schedules for implementation of validation activities.
• Conduct validation deviations and participate in deviation investigations to identify root causes and define corrective and/or preventive actions.
• Support the unit as needed to meet due dates and customer needs.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Potential relocation assistance based on business needs and/or eligibility.
• Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 10% of base salary.

What This Job Offers

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