Thermo Fisher Scientific Validation Manager in Greenville, North Carolina
When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
Directs the development and implementation of validation test procedures to ensure product(s) meet appropriate regulatory agency validation requirements, internal company standards and industry current practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Designs, implements, and documents validation for manufacturing processes, equipment, and systems for multiple business units.
Develops, approves, executes, and presents all validation master plans and associated documentation in the new drug application (NDA) drug approval process under the Food & Drug Administration (FDA) pre-approval inspection programs.
Facilitates audits of inter-departmental validation programs and negotiates the scheduling of resources for validation projects with outside vendors to support business units.
Plans and establishes technical processes, communications, document flows, testing requirements, and financial resources to ensure validation of systems. Leads project team activities and process designs to ensure compliance with current Good Manufacturing Practices (cGMP).
Represents the department during audits and meetings with regulatory agencies and clients. Provides responses to regulatory and client deficiency letters and audit observations.
Provides guidance to vendors, contractors, and other subsidiaries with process validation requirements supplying US and international markets for facility and product approval under current regulatory policies and procedures.
Bachelor’s degree in biological science, chemistry, engineering or related field.
Ten years of validation experience in the pharmaceutical industry preferred.
Three to five years management experience.
Good knowledge of sterile and non-sterile pharmaceutical manufacturing, control systems, technology, validation practices/processes, and current Good Manufacturing Practices (cGMP).
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint.
Effective written, interpersonal, and presentation skills.
Ability to work on multiple projects simultaneously.
Ability to travel as needed.
Ability to drive functional, technical and operational excellence.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
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.
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.