Equipment Validation Specialist

Las Piedras, Puerto Rico · Biotech/Pharmaceutical

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.