C&Q Engineer

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C&Q Engineer (USP)

ND Reference : JDSG201700.000.01CQE

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

The Commissioning Lead is responsible for planning and executing of the commissioning activities related to one (or several) process package(s) and for meeting the agreed objectives regarding budget, schedule, and functionality according to URS, GMP, Safety and environmental objectives.

General Description:

  • Reporting to the CQ Execution Coordinator.
  • Attend 8 am morning Coordination meeting, providing an update on issues and ‘showstoppers’
  • Overall responsibility for HSE matters in appointed area;
    • Implementation of HSE Plan & PTW WIN
    • Awareness training & implementation of GPE LOTO and SWMS/RA PSP
    • ‘Effected Area Owner’ signature (Appoint Designee)
    • Housekeeping
    • Audits with support from HSE manager
  • Overall Coordination within appointed area;
    • With CQ Execution Coordinator – Schedule, Priorities, and Execution Matters
    • With CQ Technical Document Coordinator
    • With Project Quality + QMC – Quality Matters
    • With Automation – MTS, EM or Ops issues / readiness
    • With Area Leads – Technical Matters & Handover
  • Support Project Controls function within appointed area;
    • Coordinate with PL’s w.r.t critical path and 2 weeks look ahead
    • Maintain ‘whiteboards’
    • Planning
    • Measurement of ‘Actual’ progress
    • Forecasting
  • Leading and coordinating the commissioning field team including commissioning and qualification engineers, AEI experts, user operation and site engineers, document controllers and external vendors and contractors
  • Troubleshooting and resolution of Process related issues in a timely manner with Area leads
  • Management and coordination of individual commissioning teams w.r.t holidays, ‘shift’ and User training
  • Verifying the fulfillment of test pre-requisites (general as well as test-specific)
  • Ensuring that all team members have got their safety training and other commissioning execution training
  • Execution of commissioning tests, together with commissioning field teams; including non-Q-relevant as well as Q-relevant tests
  • Recording of test results at the appropriate test specifications
  • Progress reporting towards the commissioning lead
  • Recording of deficiencies and deviations
  • Remediation activities
  • Completing the compilation of all test results within the commissioning test reports
  • Reviewing the commissioning test reports and ensuring their completeness
  • Confirming the completion of the commissioning execution

 

Considerations / Requirements:

  • A Degree in Engineering or Science disciplines
  • At least 5 – 7 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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