Instrument and Computer System Validation Manager

Pfizer • Sanford, NC

20h • Onsite

About The Position

Pfizer Sanford provides Drug Substance and Drug products to facilities around the globe. This position works as part of a cross-functional team to perform technical tasks as they relate to support for different validation program efforts, including equipment validation, computer system validation, process validation cleaning validation. These validation efforts will help ensure that our equipment, systems, and processes are reproducibly functioning as intended to support our efforts to manufacture medicines for patients. As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate explaining difficult issues and establishing consensus between teams. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

Requirements

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Relevant experience/degree must be in engineering or science (for example, biology, chemistry, biochemistry, materials or computer science).
• Demonstrated experience with computer system validation - life cycle management.
• Skilled in Microsoft Word and Excel.
• Ability to work in a team environment and complete tasks independently.
• Technical writing and evaluation skills.
• Ability to enter and navigate cleanroom type environments in manufacturing facilities.
• Permanent work authorization in the United States.

Nice To Haves

• Experience with risk-based approaches (risk assessments).
• Previous experience with Electronic Validation Document Management System.
• Previous project management/project lead experience, including oversight of contractors.

Responsibilities

• Provide guidance and support for the qualification, verification and validation of Analytical instruments, computer systems and controls in compliance with internal guidance & external regulations.
• Authoring of technical reports (periodic reviews, validation plans, protocols, and reports) or assessments (materials or components).
• Facilitating reviews/seeking feedback from multiple internal or external stakeholders.
• The position requires execution of multiple projects at the same time and good communication skills to keep, peers, and area management up to date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.
• Liaise with site functions such as Manufacturing, Planning, QA, QC, Operations, and Regulatory Affairs
• Participating in right-first-time and continuous improvement relative to supported validation programs (processes or procedures).
• Will be responsible for complex projects and responsibilities.
• Planning of timelines with intermediate milestones to meet deadlines.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• additional Pfizer Retirement Savings Contribution
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior