Validation Engineer

  • Company:
    PSC Biotech
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    9 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 senior-level Validation Engineer to join our team. The candidate must have Injection Molding experience. Responsibilities Review and update (if needed) SOPs, Specifications and pFMEA Ensure all instrumentation are calibrated and/or qualified and methods are validated Develop Process Study protocols and reports Develop OQ protocols and reports for all possible configurations at the worse-case conditions Ensure protocols and reports are approved expeditiously Plan and coordinate studies Develop PPQ protocols and reports Requirements 6-10 years of Equipment and Facilities Qualification/Validation experience Injection Molding experience is required Metrology experience Process engineering and process validation experience Experience writing final reports Understanding of Function Requirements Specification (FRS) Full IQ, OQ, and PQ knowledge Experience writing and executing SOPs System Release/Turnover knowledge Experience with User Acceptance Testing and User Requirements Specifications Adequate experience and knowledge of validation risk assessments and validation summary reports Full understanding of cGMP requirements