Validation Program Manager - First Choice Staffing, LLC
West Point, IN
About the Job
FCS is actively seeking a highly skilled Validation Program ManagerĀ for their top client in the West Point, IN area. This is a direct hire / permanent opportunity offering a competitive starting salary, flexible work schedule, medical & health insurance, PTO/Vacation, Paid Holidays, opportunity for professional growth, and other great incentives!
POSITION OVERVIEW
The Program Manager will be responsible for managing a team of Engineers onsite, directing and overseeing the installation, testing, commissioning, validation, IQ/OQ/PQ development, FAT/SAT, and start-up of systems and equipment within a FDA/GMP regulated facility.
JOB REQUIREMENTS
- Bachelor's, and/or Master's Degree in Biology, Engineering, Chemistry, and/or related subject.
- Minimum of 3+ years of professional experience working in the Pharmaceutical, Biotech, Medical Device, and/or similar FDA/GMP regulated industries.
- Experience developing and managing projects through the URS, FRS, FAT, SAT, CSV, IQ/OQ/PQ.
- Background managing projects through the equipment installs, testing, commissioning and validation processes, overseeing the planning and compliance.
- Strong understanding of the GMP regulatory environment, validation, and associated subjects.
- Expertise and well-versed in cleaning / method / process validation.
First Choice Staffing is proud to be an Equal Opportunity Employer and Drug Free workplace. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.