Thermo Fisher Scientific Validation Manager in Chicago, Illinois

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

This job is located in Middletown, VA, and has been approved for full relocation package!

How Will You Make an Impact?

The Validation Manager will oversee the operations validation program and initiatives for the site. In this role you will manage and lead the operations validation team to ensure we meet current regulations (process, environmental and cleaning qualifications) and work cross functionally in a team based environment to find resolutions to validation issue,s and ensure proper qualification documentation is completed. In this lead role you will be the operations validation SME for the site!

What Will You Do?

  • Lead, coach and mentor your staff.

  • Utilize your leadership and communication skills to communicate cross functionally, and within all levels of the company, including senior management in an effective manner including strong presentation skills.

  • Utilize your knowledge of the principals of process and cleaning validation, current industry approaches, cGMP and FDA validation guidelines to advance goals forward.

  • Develop process and cleaning validation protocols, master plans, project plans, studies, and procedures.

  • Generate, review, approve, and execute process, facility, and cleaning validations.

  • Create validation master plans in conjunction with Quality Assurance.

  • Ensure routine requalification and validation activities follow the validation policy and site validation master plan, and are in line with documentation timelines.

  • Review validation documents ensuring compliance with validation requirements & good documentation practices.

  • Utilize your knowledge of cleaning validation process including MAC studies, swab sampling techniques, worst case soil classifications, manual and automated cleaning procedure development, sprayball studies, cleaning recipes and cycles for COP/CIP systems, etc.

  • Participate in peer technical review of process and cleaning validation documents developed by others.

  • Provide coaching on process and cleaning validation topics.

  • Lead groups in creation of requirements documents, risk assessments, process and cleaning validation.

  • Provide technical support in resolving process and cleaning validation related deviations including executing and managing corrective actions.

  • Manage, develop and coach the operations validation team individuals.

  • Project management including assigning resources (internal/external), tracking and metrics to leadership.

  • Oversee and manage validation contract resources including work prioritization, execution, and contractor budget.

  • Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements.

  • Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events.

  • Represent the operations validation team in client audits and regulatory inspections.

How Will You Get Here?

  • Have a Bachelor’s degree in engineering or scientific discipline or 10+ year’s validation experience in the pharmaceutical or medical device industry.

  • Have experience with supervising staff directly including hiring and performance management/coaching.

  • Be proficient with Microsoft Office, and a CAD software package (Visio® or AutoCAD® preferred).

Who We Are

The CDD business is comprised of a variety of different product lines: Diagnostic Reagents for drug of abuse screening, therapeutic and immunosuppressant monitoring, serum toxicology, endocrine, specimen validity testing, and sepsis testing; Clinical chemistry and Molecular controls; Particle Technology; and Corporate Accounts.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.