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Validation Specialist

2 months ago

Singapore ONE STOP ENGINEERING PTE. LTD. Full time
Job Title: Validation Engineer

We are seeking a highly skilled Validation Engineer to join our team at ONE STOP ENGINEERING PTE. LTD. The successful candidate will be responsible for providing expertise in EFU Validation activities, ensuring compliance with GMP regulations and industry practices.

Key Responsibilities:
  • Act as the Subject Matter Expert (SME) for E/F/U systems Qualification, project-related deviation management, and investigations.
  • Remain up-to-date with evolving GMP regulations and industry practices, contributing to the implementation of plans.
  • Coordinate and direct validation activities effectively.
  • Develop, review, and execute protocols for E/F/U systems.
  • Perform other tasks assigned by the supervisor.
Requirements:
  • At least 6 years of experience in Commissioning and Qualification of start-ups and brownfield projects.
  • Knowledge of pharmaceutical regulatory requirements (GMP) is essential.
  • Ability to ensure closure of issues with a high level of tenacity.
  • Largely self-managed with excellent communication skills to ensure all key project milestones are met.
  • Hands-on experience in Sterilization/ Steam-in-Place Validation and temperature mapping related equipment (e.g. Kaye) is a plus.
  • Hands-on experience in KNEAT and/or standard user certification is a plus.
What We Offer:

A 12-month contract with a reputable company, ONE STOP ENGINEERING PTE. LTD.

Opportunities for professional growth and development.

A dynamic and supportive work environment.