Validation Engineer

Pfizer • Rocky Mount, NC

44d • $68,600 - $110,900 • Onsite

About The Position

As a Validation Engineer you will be responsible for validating/qualifying the systems used to develop and/or manufacture products within a large manufacturing facility located in North Carolina, USA. You will ensure 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 includes Laboratory Equipment Qualifications (IQ, OQ, PQ) and requalification's for Controlled Temperature Units (CTUs) - refrigerators, freezers, incubators for material storage and autoclaves, isolators, ovens, and washers in the Quality Operations Technical Services business unit. What You Will Achieve In this role, you will: Perform activities related to qualification, GXP validation and change management of Laboratory Equipment / Systems. Participate in development/ improvement of validation programs as needed to remain current with cGMPs and industry standards. Plan, generate and execute protocols for Periodic Performance Qualifications and Periodic Reviews in accordance with frequency defined in site schedule. Evaluate test results and analyze data ensuring coordination and communication with affected functional groups. Participate in cross-functional teams to specify, install, qualify, troubleshoot, and provide resolution of issues to ensure equipment are maintained in a validated state. Support Regulatory Agency, Customer, Corporate and internal audits through preparation and presentation of laboratory equipment validation packages. Complete validation deviation records and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA). Comprehensive understanding of risk-based validation and Current} Good Manufacturing Practices (cGMP} guidelines outlined in Code of Federal Regulations.

Requirements

• Applicant must have a bachelor's degree, science, engineering, or manufacturing technology or closely related field preferred, with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
• Working knowledge of Food and Drug Administration Regulations and Good Manufacturing Practices
• Proactive, with experience in high-performance teams, strong interpersonal and project management skills
• Proficiency in Microsoft Applications

Nice To Haves

• Technical writing experience.
• Strong communication with written and verbal skills.
• Strong conflict resolution skills.
• Experience with pharmaceutical industry, validation/qualification processes and laboratory equipment.
• Ability to work independently and in a team environment in partnership with others.
• Proven ability to use initiate and drive to achieve results.
• Proficiency with Kaye Validator and Ellab instrumentation for thermal mapping calibration and qualification studies.

Responsibilities

• Perform activities related to qualification, GXP validation and change management of Laboratory Equipment / Systems.
• Participate in development/ improvement of validation programs as needed to remain current with cGMPs and industry standards.
• Plan, generate and execute protocols for Periodic Performance Qualifications and Periodic Reviews in accordance with frequency defined in site schedule.
• Evaluate test results and analyze data ensuring coordination and communication with affected functional groups.
• Participate in cross-functional teams to specify, install, qualify, troubleshoot, and provide resolution of issues to ensure equipment are maintained in a validated state.
• Support Regulatory Agency, Customer, Corporate and internal audits through preparation and presentation of laboratory equipment validation packages.
• Complete validation deviation records and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
• Comprehensive understanding of risk-based validation and Current} Good Manufacturing Practices (cGMP} guidelines outlined in Code of Federal Regulations.

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: Entry Level