Senior Validation Engineer - Drive GMP Quality & Compliance

Pfizer; Kansas; On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) + match

Job summary

Pfizer is seeking a validation specialist to lead complex projects, coordinate testing, and ensure adherence to cGMPs and Pfizer standards. You will provide high-level data analysis for Quality Investigations, author protocols, and support regulatory audits, with on-site responsibilities and potential travel.

The role requires a strong background in IQ/OQ/PQ, validation of systems, equipment, and processes, and collaboration with cross-functional teams to ensure timely completion and quality

Qualifications

• Bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience OR an associate's degree with 6 years of experience; OR a 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

Responsibilities

• Lead the completion of assigned complex projects, meet agreed targets and develop plans for work activities on projects within a team.
• Provide high level data analysis support for Quality Investigations or troubleshooting.
• Comprehensive understanding of Current Good Manufacturing Practices (part of GxP) guidelines outlined in Code of Federal Regulations.
• Ensure compliance with latest Pfizer Standards for validation and qualification activities.
• Point contact SME for routine Quality systems, such as Change Control, Quality Agreement, Documentation, Submission authoring and Investigations.
• Author or approve protocols and final reports, perform on floor executions of validations.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Maintain Site Validation Master Plan. Support regulatory audits through the preparation and interaction with auditors in areas related to sterility assurance equipment, capex qualifications, computerized systems, process or cleaning validations as assigned.
• Provide expertise for troubleshooting and resolution of issues related to sterility assurance equipment, capex qualifications, computerized systems, process or cleaning validations as assigned.
• Assess 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 or Drug Product plant support for Validation.
• Ensure integration of validation schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions. Support the unit where needed to assure due dates and customer needs are met.

Job description

Pfizer is seeking a validation specialist to lead complex projects, coordinate testing, and ensure adherence to cGMPs and Pfizer standards. You will provide high-level data analysis for Quality Investigations, author protocols, and support regulatory audits, with on-site responsibilities and potential travel.

The role requires a strong background in IQ/OQ/PQ, validation of systems, equipment, and processes, and collaboration with cross-functional teams to ensure timely completion and quality