Supervisor, Validation

Thermo Fisher Scientific•High Point, NC

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 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. 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.

Requirements

Advanced Degree, no prior experience required, or bachelor's degree plus 5 years of experience in GxP regulated environment (Validation)
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

Nice To Haves

Preferred Fields of Study: Life Sciences or Engineering

Responsibilities

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.