Validation Manager

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale...

About the Business
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.

Discover Impactful Work
The Validation Manager (C&Q) will lead commissioning and qualification activities across the site, ensuring successful execution of capital projects and operational readiness.

A Day in the Life

• 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

Keys to Success

Education

• Bachelor’s degree in Engineering, Science, Chemistry, Biology, or related technical discipline

Experience

• 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
• Experience supporting or developing early talent/co-op programs preferred

Knowledge, Skills, Abilities

• Strong understanding of cGMP’s and C&Q processes
• Project and resource management skills
• Strong leadership and organizational capability

Competencies
Leadership, Project Management, Collaboration, Accountability, Operational Excellence