Equipment Validation Specialist

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Company: ISO Group

Location: Las Piedras, PR 00771

Description:

Job Description:
  • Prepares, reviews and executes validation projects for heat-sensitive devices using vaporized hydrogen peroxide gas sterilization techniques.
  • Utilize isolator and VHP decontamination to enable Aseptic processing of Pharmaceutical products
  • Prepare VHP cycle development with a 6 Log reduction cycle with phases of Preconditions, Conditioning Dosages, Decontamination Stabilization and Aeration maintaining necessary Humidity and Air Flow
  • Responsible for mapping VHP distribution using Chemical indicator (CI) and Temperature Mapping
  • Develop BI placement and retrieval strategy
  • Design equipment & glove extender for maximum VHP penetration in between surfaces
  • Perform hands on testing with equipment, process and validation using data loggers, various instrumentation and computerized equipment.
  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory requirements
  • Perform collection of environmental samples for viable and non-viable particulates
  • Liaise with QC Microbiology, Facilities, Manufacturing and other departments for execution.

Job Requirements:
  • The position requires a minimum B.Sc in engineering or a related discipline
  • Minimum 3-5 years' of experience in a similar or related role in the Pharmaceutical or Biotechnology industry
  • Expert ability with developing and executing validation protocols, specifically for Isolator and VHP studies
  • Must have experience with the validation of processing equipment and be able to prepare, URS, FS, IQ/OQ/PQ protocols and reports
  • Investigate and troubleshoot problems which occur during the validation studies
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  • Write validation plans related to specific projects and facilities
  • Conduct validation risk assessments related to specific projects and facilities
  • Have the capacity to demonstrate ability to plan and execute appropriately on moderately advanced tasks and/or projects within their technical expertise
  • Must have a thorough knowledge of cGMP and regulatory requirements for validation of equipment and computerized systems in the biopharmaceutical or pharmaceutical industry
  • Excellent protocol and report writing skills, detail orientation, problem solving skills
  • Proven record of excellent verbal and written communication skills
  • Must be proficient in Microsoft Office (Word, Excel, PowerPoint, etc)
  • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide program updates and reviews.

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