Supervisor, Validation

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

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Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location Information:

High Point, NC

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How will you make an impact?

The Supervisor, Validation will be responsible for leading the day-to-day activities of the validation team in areas of Facility/Utility, Lab Equipment, Computerized Systems, Cleaning and Process Validation. This role will provide technical support to internal and external customers; planning, executing, and analyzing validations; and managing site validation activities.

What will you do?

• Supervises daily operations of the Validation team specifically in the areas of Facility/ Utility/ Automation/ Laboratory/ Computerized Systems, and Cleaning and Process Validation.
• Responsible for the validation activities inclusive of the site validation master plan
• Planning, coordinating, and leading the team to meet project requirements are adhered to.
• Daily solving, process optimization, technical review of process issues and increased efficiency via continuous improvement measures.
• Develop and implement related policies, procedures, and trainings to ensure consistency and efficiency. Assures that activities are conducted in compliance with US and EU regulations, EHS requirements, and global policies.
• Sets measurable and achievable individual goals; leads and motivates team to achieve their targets.
• Generate, review, and approval of protocols, reports, SOPs/WIs, investigations, risk assessments, and change controls. Tasks include execution of validation, data analysis, and coordination support resources, as needed.
• Maintains inventory of GxP related equipment and associated periodic review activities.

REQUIREMENTS:
• Advanced Degree, no prior experience required, or bachelor's degree plus 5 years of experience in GxP regulated environment (Validation)
• Preferred Fields of Study: Life Sciences or Engineering
• Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment
• Strong understanding of Validation Lifecycle (GAMP 5) principles
• Experience with calibration and maintenance management software
• Knowledge of electronic document management systems
• Experience with data integrity practices and compliance
• Strong technical writing skills for qualification documents, SOPs, and work instructions
• Ability to manage multiple projects simultaneously with minimal supervision
• Detail-oriented with excellent verbal and written communication abilities
• Ability to adapt to changing priorities in a deadline-oriented environment