Commissioning Engineer

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Commissioning Engineer
ND Reference: JDSG1705075.01CQE

Position available with No Deviation Pte. Ltd. supporting a MNC Client in the pharmaceutical industry

The Commissioning Engineer shall provide hands on execution support for C&Q commissioning test executions, he/she shall be able to safely execute allocated tasks under the asperses of GMP/GEP without the requirement for direct supervision.

General Description

  • Reporting to the Commissioning Lead
  • Execution of allocated commissioning tests activities, (non-Q-relevant as well as Q-relevant tests).
  • As and when required support in execution of static commissioning tests and in preparation of commissioning test plans and specifications as well as operation functional specifications for process package(s).
  • Preparation and execution of pre-requisite activities for dynamic and static commissioning test executions.
  • Be IT literate and familiar with Microsoft office suite of applications.
  • To accurately and consistently record test results in the appropriate commissioning and qualification documentation according to GDP. To include recording of deficiencies and deviations, as and when required pursue deficiencies and deviations to closure.
  • Planning/managing of daily work load, timely and efficient reporting of events to line management.
  • Timely execution of instruction as directed by supervision and line management.
  • To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle.
  • To work within a site quality framework, to follow company standard operating procedures and be quality and safety focused in all activities.
  • To be self-starting and demonstrate initiative and competency at his or her experience level.
  • Be able function successfully in high pressure fast moving multi-discipline/multi- cultural project environment.
  • To be responsible and aware of his/her own safety and the safety of those around them whilst executing C&Q works within a construction site environment.
  • To follow implicitly all site/project safety procedures and policies. Timely reporting of safety incitements/accidents and or observations.

Considerations / Requirements:

  • A Degree in Engineering or Science disciplines
  • At least 3 years’ relevant experience working specifically in the pharmaceutical industry
  • Previous C&Q experience with the above systems preferred
  • Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
  • Proactive, Self-starter and Capable of Working alone or in a team environment
  • Good knowledge of cGMP and GDP
  • Knowledge of ASTM E2500 approaches to C&Q
  • To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle.
  • Be IT literate and familiar with Microsoft office suite of applications.
All applications will be held in the strictest confidence with no information shared externally without prior consent.

 

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