Validation Engineer

  • Company:
    PSC Biotech
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    11 hours ago
  • Category:

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date. We focus on providing quality consulting services to ensure our clients success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customers expectations. We are looking for a Validation Engineer to join our team responsible for the validation of manufacturing equipment used for assembly of rapid diagnostic tests and process validation in support of process changes. Responsibilities Responsible for performing the validation of equipment, cleanrooms, fill lines, UV-VIS, Vision Systems, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports. Verifies that CAPAs are proactively identified, documented, tracked, and implemented Lead process validation in support of process changes. Perform all required IQ, OQ, and PQ, tasks Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget. Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work. Reviews protocols, reports and data tables generated by peers and contract personnel. Represents the department on cross-functional project teams. Requirements 2-5 years of Validation experience Advanced understanding of IQ, OQ, and PQ activities Adequate understanding of Process Performance Qualification procedures and activities Ability to prepare and execute SOPs Good Documentation Practice Strong background and experience in Validation and GMP regulations. No Sponsorship No C2C No Third Party Resumes #PSC