Validation Manager

Thermo Fisher Scientific Inc

Greenville, NC

JOB DETAILS
SKILLS
Automation, Biology, Biotech and Pharmaceutical, Capital Project, Chemistry, Commissioning, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Development, Drug Manufacturing, Engineering Management, Facilities and Maintenance, Leadership, Manufacturing, Mentoring, Organizational Skills, People Management, Process Engineering, Project Commissioning, Project Planning, Project/Program Management, Quality Engineering, Resource Management, Sales Qualification, System Start-Up, Talent Management, Team Lead/Manager, Validation Plan
LOCATION
Greenville, NC
POSTED
30+ days ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

About the Company

T

Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html