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Sr. Computer Systems Validation Specialist

Have you been looking for a new and exciting opportunity with a biotech company that is helping change lives? Are you interested in working for a company that has a global presence! This is the opportunity for you! My client is a specialty nuclear medicine provider in the St. Louis area, looking for a Senior Computer Systems Validation Specialist. This role will be structured as a 6 month contract, paying $45 to $55 an hour based on prior job experience.

As a Sr. CSV Specialist, candidates would 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 as well as its related support area. This may include Facilities/ Engineering, Quality Assurance, Supply Chain, and Quality Control.

The day-to-day responsibilities of the Sr. CSV Specialist will include, but no be limited to:

  • Author, review and/or approve cGMP assessments, user requirements and functional specifications, validation plans. Qualification test protocols (ie. IQ, OQ, PQ), reports, addendums and other validation efforts as required. * Managing and coordinating all aspects of the 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. * Complete periodic reviews of cGMP systems, instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state

The most ideal candidates should possess the following qualifications:

  • Bachelor Degree required in a Science or Engineering related discipline. (Nuclear or Chemical related fields preferred.) * 5 to 8 years of experience in the laboratory instrument validation field including those with computerized systems attached in a cGMP environment required * 5 to 8 years of experience in the pharmaceutical industry or relevant business experience within Quality Control or Validation cGMP Compliance * Experience operating/ maintaining instrument systems including Gamma/ Alpha Spectroscopy related to Canberra/ Mirion Instrumentation preferred

This position offers an exciting opportunity to be a part of a company that works with exciting specialty brands.

If you are interested in learning more about this opportunity, please forward your resume and/or contact me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.