Validation Manager
About The Position
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our Pharma Services Group (PSG)—a global leader providing integrated drug development and manufacturing solutions to pharmaceutical and biotech companies. Our Greenville, North Carolina site specializes in sterile and oral solid dose (OSD) manufacturing. The Validation Manager (C&Q) will lead commissioning and qualification activities across the site, ensuring successful execution of capital projects and operational readiness. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Requirements
- Bachelor’s degree in Engineering, Science, Chemistry, Biology, or related technical discipline
- 6+ years of experience in commissioning, qualification, and/or validation within pharmaceutical or regulated manufacturing environments
- Minimum 3+ years of leadership experience, including managing engineers and/or contractor teams
- Hands-on experience supporting capital projects, including commissioning and qualification of new equipment and systems in a Steriles Manufacturing facility
- Experience reviewing and approving technical project plans, validation strategies, and execution approaches
- Proven ability to manage highly effective teams (FTEs + contractors) and a complex portfolio of concurrent projects
- Experience collaborating cross-functionally with quality, process engineering, automation, facilities, maintenance, and operations
- Strong understanding of cGMP’s and C&Q processes
- Project and resource management skills
- Strong leadership and organizational capability
Nice To Haves
- Experience supporting or developing early talent/co-op programs preferred
Responsibilities
- Lead ~6 direct reports and ~25 contractors
- Manage commissioning & qualification (C&Q) activities
- Review and approve capital project requests
- Allocate resources and manage workload across projects
- Support equipment implementation and startup
- Mentor team members and develop co-op pipeline
- Collaborate cross-functionally across site functions
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
