Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

• Lead and further develop the Validation and Technical Services Department!
• Responsible for the preparation, execution, and eventual review and approval of documentation (SIA, URS, RA, FAT, SAT, VP, IQ, OQ, PQ, TM, PPQ) as well as the generation of corresponding summary report
• Achieve and maintain a level of Validation expertise for all systems and processes at the site in order to coach and mentor junior validation engineers
• Continuously look for means to optimize processes to improve compliance and efficiency.
• Lead meetings and participate in other discussions to acquire agreement on Validation approaches.
• Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices).
• Coordinate Validation Projects and ensure project timelines
• Drive maintenance of the Validation Master Plan (VMP) as needed
• Demonstrates and promotes the company vision of the 4 I's: Integrity, Intensity, Innovation, and involvement
• Author SOPs related to validation/revalidation activities
• Demonstrate sound decision making related to priorities
• Conducts all activities in a safe and efficient manner

• Bachelor degree from an accredited college or university, preferably in Engineering or a Science-based subject.

• 5+ years of validation experience in a regulated industry.
• Pharma engineering experience
• Experience with regulatory requirements as applied to the qualification and management of Controlled Temperature Unit (CTU) Operation
• Knowledge and experience with IQ's PQ's & OQ's with GMP experience
• Knowledge of the lifecycle of Validation documentation is required
• PC literacy including the ability to generate documents in both Microsoft Excel and Microsoft Word
• Must be prepared to provide direction and leadership to team and external functions and activities
• Must exhibit Interpersonal skills; analytical skills; ability with multitasking/shifting priorities
• Be results oriented

• Be able to lift 35 pounds