Process Consultant

JUDGE Research is a leading provider of managed services to the life sciences industry.  As a specialized division of the JUDGE Group, we are comprised of three complimentary practice areas: Clinical Research, Regulatory Affairs, & Federal Services. Combined with the JUDGE Group?s 35 years of expertise in Human Capital Management, Talent Acquisitions, Training Services and Business-Technology Solutions, JUDGE Research is uniquely positioned to provide a full suite of support to our Pharmaceutical, Biotechnology, Medical Device and governmental research institutes.  We at JUDGE Research are looking forward to having you as part of our team.

Computer Systems Validation (CSV) needed to help wrap up 21 CFR Part 11 remediation work for PLC ans SCADA controls systems running Fermentors, Centrifuges, Bioreactors and skids.  Candidates should demonstrate an in-depth knowledge of validation processes and programs, familiarity with pharmaceutical/biotech processes, and familiarity with documentation in a highly regulated environment.  Candidates will also need in-depth knowledge of 21 CFR Part 11, and electronic record/electronic signatures(ER/ES) .

 

Requirements:

 

3+ Year of operations/validation experience; Direct experience performing work per FDA, cGMP, OSHA and /or EPA strict guidelines.