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 quality assurance team. You will be responsible for evaluation, review and approval of validation master plan, 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.

As a Senior Validation Engineer, you will be responsible for validating/qualifying the systems used to manufacture drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products. The area of responsibility will be the Equipment/Facility/Utility Qualifications (IQ, OQ, PQ) and requalification's in the Sterilization, Formulation and Commodity Preparation business unit areas.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.

• Coordinates and communicates all testing with affected functional groups and evaluates test results.

• Executes equipment validation studies to include protocol preparation, scheduling, execution, including data analyze data and generation of summary reports.

• Participates in presentation of results to Regulatory Agency, when necessary.

• Support regulatory audits through the preparation, defense and interaction with auditors in areas related to equipment, instrumentation, facilities and utilities

• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.

• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.

• Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).

• May supervise and/or mentor junior level engineers.

• Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, 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.
• Ensure integration of validation schedule in production schedule for implementation of validation activities
• Initiate 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.

Qualifications

Must-Have

• Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience;
• OR an Associate's degree with six years of experience;
• OR a Bachelor’s degree with at least three years of experience;
• OR a Master’s degree with more than one year of experience.
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
• Must be able to interact with varying levels within the company
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
• Strong conflict resolution skills
• Must be able to work multiple shifts as needed to meet deadlines

Nice-to-Have

• Relevant pharmaceutical experience.
• 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

PHYSICAL/MENTAL REQUIREMENTS

Must be able to lift and carry light loads as necessary in conducting testing. May involve standing for long periods of time. Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements. Ability to multi-task and keep several activities and projects moving forward in order to meet defined timelines is a must.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Primary work schedule is Day shift, Monday – Friday but evenings, weekends and holiday work will be required, as needed. Some travel, < 10% may be periodically required.

Relocation support available: Yes
Work Location Assignment: On Premise

Last date to apply: 6/7/2023

Relocation assistance may be available based on business needs and/or eligibility.