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TS Engineer_Lead Compliance

Singapore · Novartis Singapore Pharmaceutical Manufacturing Pte Ltd.

Openings: 1

<p>&nbsp;Strategy &amp; Organizational Development:<br />
&bull; Support internal and external audits<br />
&bull; Lead or contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance)<br />
&bull; Own the Training Curriculum for own Job Profile<br />
&bull; Train operators and / or technician<br />
<br />
Maintenance &amp; Calibration:<br />
&bull; Establish maintenance &amp; calibration plan content<br />
&bull; Enter master data into CMMS (e.g. confirmation and technician time allocations)<br />
&bull; Coordinate maintenance / calibration activities<br />
&bull; Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)<br />
&bull; Enter work orders into CMMS for maintenance / calibration<br />
&bull; Develop method statement for maintenance / calibration<br />
&bull; Perform risk assessment for maintenance / calibration<br />
&bull; Provide frontline support for technicians<br />
&bull; Supervise maintenance / calibration work<br />
&bull; Assess quality impact and release after maintenance<br />
&bull; Assess equipment fit for purpose<br />
&bull; Set-up maintenance for new equipment (incl. spare part needs)<br />
&bull; Develop, monitor and improve KPI for maintenance &amp; calibration<br />
&bull; Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML)<br />
&bull; Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request<br />
&bull; Execute Change Requests<br />
&bull; Investigate deviations (Root Cause Analysis)<br />
&bull; Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)<br />
&bull; Plan spare parts (order spare parts, manage master data, minimum order quantity, documentation)<br />
&bull; Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements)<br />
<br />
Project Engineering &amp; Control:<br />
&bull; Identify technical solutions<br />
&bull; Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification)<br />
&bull; Develop project turn over plan<br />
&bull; Perform new equipment FAT / SAT / inspections in project<br />
&bull; Perform commission activities<br />
&bull; Manage project deficiencies and deviations<br />
&bull; Perform provisional and final project handover<br />
<br />
(Re-) Qualification:<br />
&bull; Provide technical trouble shooting during PQ and validation<br />
&bull; Develop periodic requalification plan<br />
&bull; Execute periodic requalification plan<br />
<br />
Automation:<br />
&bull; Develop &amp; implement Coding / Recipes (DCS / Scada / PLC&rsquo;s / Control Networks)<br />
<br />
Technical Services Operation:<br />
Drive / improve Technical Services (infrastructure, utilities), availability, reliability<br />
<br />
Key Performance Indicators (Indicate how performance for this role will be measured)<br />
&bull; Improvement projects according to plan.<br />
&bull; Maintenance and Calibrations plans approved and executed as planned.<br />
&bull; No out of compliance calibrations.<br />
&bull; Meet ratio preventive / corrective maintenance.<br />
&bull; Equipment availability, reliability, effectiveness.<br />
&bull; Mean time between failures (MTBF), mean time to recover (MTTR).<br />
&bull; Spare part inventory.<br />
&bull; Meet maintenance cost efficiency.<br />
&bull; No critical findings in internal / external audits on qualifications.<br />
&bull; Requalification plans approved and execute as planned, no major deviations, no overdue CAPAs.<br />
&bull; Highest safety standard implemented during projects and operations, no critical findings in HSE audits, no LTI and SIF<br />
<br />
Education (minimum/desirable):<br />
Degree in Engineering (Dipl. lng. / M. Sc. / B. Sc. or equivalent<br />
Languages: Fluent in English and proficient in local language<br />
Experience: Experience in Pharma Industry desired, ideally in Engineering or Operations type roles.<br />
<br />
CANDIDATE REQUIREMENT<br />
Qualifications required: Degree<br />
Number of years of experience including industry: 1-3 year in pharma industries<br />
Systems/Software Experience Required: Microsoft Office<br />
Essential Skills (why are they essential?): Fluent in English</p>
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