Senior Validation Engineer

2 weeks ago


Singapore Pm Asia Project Services Pte. Ltd. Full time

Responsibilities

  • Generation and execution of validation protocols and reports (including IQs, OQs, PQs, QAPs, etc.).
  • To lead and/or support validation projects and activities on site, as directed and as appropriate.
  • To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan.
  • Commissioning and validation of various new technologies and new equipment.
  • To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
  • Leading and supporting SATs.
  • Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
  • Ensuring manufacturing equipment is qualified in line with production schedule requirements.
  • Developing and writing validation procedures according to cGMP and regulatory requirements.
  • Generating and executing validation documentation.
  • Providing continuous improvement for existing validation procedures.
  • Data collation and analysis via sophisticated computer software.

Requirements

  • Applicants will have a minimum of 10 years of experience in equipment validation on multiple projects in the pharmaceutical, biopharmaceutical or food sectors.
  • Experience with temperature mapping, clean utilities and HVAC qualification are essential.

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