RCM Technologies Empower Validation Project in Cambridge, Massachusetts
Reference # :21-00369Title :Empower Validation ProjectLocation :Cambridge, MAPosition Type :ContractExperience Level :Start Date / End Date :06/21/2021 / 09/21/2021 Description RCM Life Science is seeking a Senior CSV consultant to support a validation project at our client. This position will provide computer system validation support of the Waters Corporation Empower 3 FR3 software . Draft and review computer system validation lifecycle documentation (Plans, Requirements, Protocols, Summaries, etc.). Support key validation projects to ensure timely completion and serve as a computer system validation representative on project teams. Ensure that computerized systems are maintained in a manner compliant with corporate and regulatory requirements.A Qualified Candidate must have the following:
Previous experience and knowledge of regulatory requirements related to computer system validation (including 21 CFR Part 11).
Understanding and experience validating applications following a Risk Based Approach (RBA)
Qualified and Validated equipment and computer systems in a laboratory environment.
Experience developing and reviewing Validation document set.
Experience with leveraging/authoring OQ and PQ protocols across sites; execution and writing of tests scripts
Previous experience in a regulated environment is desired (10 years of computer system validation experience).
Must maintain a working knowledge of cGMP and cGXP regulations related to laboratory and database applications
Excellent teamwork and communication skills (both oral and written) required. Attentive to detail.
Ability to take initiative, to be assertive, and to build quality working relationships.
Must have experience with Waters Corporation Empower 3 FR3 software .
Work will be performed onsite/remote.
6-10 years of experience in validation in Pharmaceutical industry
Familiarity with Waters Empower Software
Experience validating UPLCs in a Lab environment
Familiarity with FDA and EU regulations for pharmaceuticals and medical devices
Strong technical writing skills are required to author validation documentation
Ability to work semi-independently; demonstrated ability to interact well with other technical departments
RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. RCM Technologies , (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages.