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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.

    Requirements

  • 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.

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