Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective technical service's Validation team. You will be responsible for evaluation, review and approval of validation master plan, change controls impact assessment, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for validation process documents and technical reports related to equipment, products and processes.

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team. Schedules and executes validations/qualifications per project requirements, Standard Operating Procedures (SOPs) and regulatory guidelines.
• Author, execute, or review Validation documents such as: Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, equipment qualifications, PQs, and Deviation Handling.
• Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
• Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.
• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems, processes, or equipment.
• Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Provide expertise for troubleshooting and resolution of issues related to equipment, instrumentation, qualifications, facilities and utilities.
• Assess potential impact of changes to qualified systems Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary.
• Support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.
• Support and lead assigned product transfers/new product development, regulatory queries, cost improvement projects or technical projects.
• 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.

• Bachelor's degree in engineering, Science, or related field and 5+ year experience in a cGMP, quality or validation environment OR Master's degree with a minimum of 3+ years of experience.
• Ability to work independently with limited managerial oversight
• 3-5 years of direct hands-on experience on one or more of validations expertise like: sterilization validations, media fills, equipment qualifications, CSV etc.
• Strong understanding of cGMPs, ISPE, Data Integrity, 21 CFR Part 11 and Annex 1 regulations, industry good practices for IQ/OQ/PQ and Standard Operating Procedures.
• Experience in {Current} Good Manufacturing Practices {part of GxP}.
• Strong working knowledge of a variety of quality systems and processes.
• Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System.

• Prior experience working with assessing/qualifying/testing components
• 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.
• Experience or familiarity with Kneat electronic validation solutions.

• Requires routine sitting, standing, walking, listening and talking
• Acute mental and visual attention at all times
• Handle multiple projects while managing frequent interruptions
• Requires moderate lifting or moving up to 25 pounds (lbs)

• Requires regular onsite attendance
• Must have the ability to work effectively under strict deadlines
• Must be able and willing to work beyond office hours which may include weekends and holidays
• Must be capable of supporting up to 10% travel (domestic and international)