Senior Validation Engineer

Pfizer

3d • Onsite

About The Position

At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. In this role, you will: 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.

Requirements

• 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

Nice To Haves

• 5+ years of direct validation experience in minimum one of the field of validations: Equipment qualifications, CSV, Aseptic validations, process or cleaning validations.
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices
• Exposure to multiple validation workstreams

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.

Benefits

• 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: Senior
• Number of Employees: 5,001-10,000 employees