Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance. We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.
Scope of Position: The Validation Engineer will provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified in a cGMP Manufacturing Facility.
Author cGMP risk assessments, user requirements and functional specifications, validation plans, qualification test protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation efforts as required.
Perform computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews.
Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.
All other responsibilities as assigned with or without accommodation.
Pay Rate: $50.00 hr
Length of time: Long term contract 12-48 months