The Lead Validation Specialist is a new position within the Chesterfield Manufacturing Facility (CMF) organization. This position is responsible for oversight of sustainable validation programs in support of GMP manufacturing. The CMF is responsible for manufacture of DNA plasmid starting material derived from microbial culture processes, and Regulatory Toxicology supplies in support of Pfizer's gene therapy portfolio. This position will be a part of the newly created CMF Operations Support team.ROLE RESPONSIBILITIES
- Oversight of sustainable validation program and ownership of Validation Master Plans.
- Lead and perform periodic reviews on GMP equipment, re-qualification of GMP autoclaves, re-mapping of chambers.
- Author qualification protocols for new equipment and ensure execution of qualification activities.
- Support qualification activities required by change controls (equipment and automation).
- Support all change controls, investigations and audits as needed.
- Interact with operations and engineering to understand equipment/project requirements and coordinate qualification timing and resources.
- Provide direction to junior colleagues on work tasks.
- Bachelors in an engineering, scientific or related discipline
- 10+ years of experience in regulated industry
- Demonstrated experience in a matrix team environment and interacting with Project Management, Manufacturing, Compliance, and Quality. Direct experience with equipment validation highly desired.
- Strong attention to detail, along with excellent communication and collaboration skills.
- Strong decision-making skills, routinely demonstrated in highly complex environments.
- Ability to work independently and complete deliverables with little guidance.
- Experience in a cGMP environment with increasing responsibility is desired. Management experience is also highly desirable.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Collaborative skills and effective partnering skills in complex working environments
- Ability to work in a dynamic multi-discipline organizational model
Other Job Details
- Ability to work in a clean room environment
Relocation support available
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