My name is Thomas Gillitzer and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Senior Validation Engineer for a prominent client of ours. This position is located in Somerset, NJ. Details for the position are as follows:
- Responsible for managing, developing and implementing Equipment and Facility Validation program to ensure compliance with regulatory agency requirements, internal company standards and current industry practices.
- Design, develop and lead Equipment and Facility Validation initiatives.
- Ensure that the Validation Master Plan remains current.
- Write, review and execute Equipment and Facility Validation protocols to ensure compliance and adherence to CGMP and validation standards.
- Initiate a problem report (change control, CAPA etc) in a TrackWise system.
- Resolve all non-conformances/deviations and prepare a final summary report for Equipment/Facility Validation protocols.
- Liaise with manufacturing and laboratory groups in execution of the Validation program.
- Degree (Bachelors or Masters) in a technical discipline.
- Preferred Five (5) to seven (7) years in a CGMP-related industry with at least three (3) to four (4) years of validation industry experience.
- Code of Federal Regulations and CGMP's relating to the field of validation
- In depth knowledge of FDA guidelines and ISPE guidelines
- Demonstrated understanding of process and mechanical engineering
If you are interested in hearing more about the position please respond to this posting with your resume attached
The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field
The Fountain GroupLooking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field