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 Validation team. As a Validation Associate Engineer you will be responsible for validating/qualifying the processes, systems, equipment, facilities, and/or utilities used to manufacture and/or clean drug products within a large manufacturing facility located in North Carolina, USA. You will help to demonstrate that the processes and/or systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

As an associate engineer, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.  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

• Draft, schedule and execute validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines
• Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Execute validation activities to include, but not limited to: Change Control initiation, protocol preparation, periodic reviews, routine requalification, scheduling, protocol execution, data review and final report generation.
• Participate and/or present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
• Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.
• Participates on teams assembled to specify, install, validate, troubleshoot and maintain processes, systems and equipment.
• Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• .Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Create, review and approve deviations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

Qualifications

Must-Have

• High School Diploma (or equivalent) with 6 years of relevant experience,
• Or an Associate's degree with 4 years of experience,
• Or a Bachelor's degree with 0+ years of experience.
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills
• Excellent attention to detail
• 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

Nice-to-Have

• Be proactive, have experience with high performance teams, strong interpersonal and project management skills
• Experience at a pharmaceutical manufacturing site
• Some knowledge and experience with equipment, facility, utility or computer system validation, as related to sterile products and medical devices preferred
• Experience of writing and managing deviations
• Experience in production batch record review, investigation of non-conformance, root cause analysis and change control management

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.
• 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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Primary work schedule is Day shift, Monday – Friday, but evening, early morning (off shift), weekend and some holiday work will be required, as needed.  Some travel, < 10% may be periodically required.