We are currently looking for potential candidate to provide expertise in EFU Validation activities. Contract period will be 1 year and availability as soon as possible.
Below are the requirements for Validation Engineer (Equipment/ Facilities/ Utilities):
Major Responsibilities:
- Act as the Subject Matter Expert (SME) related to E/F/U systems Qualification, project related deviation management and investigations.
- Remain abreast of continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems and contribute to the implementation of plans.
- Coordinate and direct validation activities actively.
- Generate, review and execute protocols for E/F/U systems.
- Perform other tasks as assigned by supervisor.
Qualifications/ Skills:
- At least 6 years and above of working experience and knowledge on Commissioning and Qualification of start-ups and brownfield project experience.
- Knowledge of pharmaceutical regulatory requirements (GMP) is essential.
- Shows a high level of tenacity to ensure closure of issues.
- Largely self-managed with ability to communicate upwards and cross-functionally 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.
Interested candidates, please send in your updated resume to [email protected]
Job Types: Full-time, Contract
Contract length: 12 months
