Senior Validation Engineer

Use Your Power for Purpose

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.

What You Will Achieve

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.

Here Is What You Need (Minimum 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

Bonus Points If You Have (Preferred Requirements)

• 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

PHYSICAL/MENTAL REQUIREMENTS

• 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)

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• 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)

Other Job Details:
Relocation support available
Work Location Assignment: On Premise

Last day to apply: 11/21