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MaAN001 Commissioning Process Engineer

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Posted: 24 Apr 2008
Location: China
Responsibilities:

1. Ensures fully operational unit at the point of handover to operations.
2. Plan & manage commissioning and qualification work with commissioning team and sub-contractors. Complete all necessary planning and preparation work prior to start testing. Coordinate with qualification to issue required IQ forms in time to contractors (SMEIC, NTCC, others as required).
3. Write commissioning testplans (for GMP units IQ- and OQ test specification) and get them approved by commissioning area coordiantor, operations and validation.
4. Execute IQ & OQ and resolve all deficiencies. Execute tests including documentation. Assess test results and decide, if process and operations requirements are met. If process or operations requirements are not met initiate changes in hard- and software including retest and documentation to fulfill requirements.
5. Coordinate day to day commissioning activities across all involved parties (construction, mechanical function testing team, electrical crafts, automation engineers, instrumentation crafts, others).
6. Overall responsibility for closing out open items. Maintain task list (access database). Follow up on task list items with construction. The unit owner is responsible for close out of items even tasks are assigned to others.
7. Provide complete documentation (for GMP units complete IQ / OQ binder) at handover to operations.
8. Organize handover from construction to start-up team, including several walk downs. Organise walkdown with user, safety department.
9. Clear deficiency lists at the point of handover [a) handover construction to unit owner, b) handover unit owner to opertions]
10. Ensure all comments received from reviewers/approvers on the test scope (pre execution of tests) and on test results (post execution of test.) are incorporated in a timely fashion to facilitate close out of the commissioning and handover to operations.
11. Assist MFT (= mechanical function testing) activities like flushing lines, leak test on equipment, level calibration of vessels, rotation tests on motors, filling lubricants, etc)
12. Check as built documentation (functional specification automation, PID, loop diagrams, etc) including vendor documentation.
13. Fixes all upcoming problems during testing in an efficient way.
14. Communication of commissioning progress, completion status etc. to Commissioning Area Lead, Commissioning Managers or designees.
15. Train operators and bring them to a level to be able to execute test themselves.
16. Organise handover of unit from commissioning team to operations.

Requirements:
Commissioning or operational experience in the chemical and/or pharmaceutical industry;

Experienced in leading up to 5 associates;

Several years of engineering or production experience in the chemical / pharmaceutical industry;

Ability to challenge deficiencies to minimize changes;

Degree in engineering or chemistry,/ or senior designer, senior operator;

GxP knowledge;

HSE knowledge;

Knowledge of Novartis standards, guidelines and processes concerning commissioning.

Contact Information:

Please mention Misco Jobs when applying to this position.
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