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Pfizer · 1 day ago

Senior Validation Engineer

Kansas, United States

Full-time

Onsite

Mid, Senior Level

2+ years exp

Pfizer is a company dedicated to improving patients' lives through innovative solutions. In this role, you will lead complex validation projects, ensure compliance with Good Manufacturing Practices, and support regulatory audits while collaborating with various functional groups.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

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

Qualification

CGMPsValidation experienceData Integrity21 CFR Part 11Technical knowledgeCommunication skillsExposure to validation workstreamsWork independently

Required

Applicant must have a 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