TS Engineer_Lead Compliance
<p> Strategy & Organizational Development:<br />
• Support internal and external audits<br />
• Lead or contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance)<br />
• Own the Training Curriculum for own Job Profile<br />
• Train operators and / or technician<br />
<br />
Maintenance & Calibration:<br />
• Establish maintenance & calibration plan content<br />
• Enter master data into CMMS (e.g. confirmation and technician time allocations)<br />
• Coordinate maintenance / calibration activities<br />
• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)<br />
• Enter work orders into CMMS for maintenance / calibration<br />
• Develop method statement for maintenance / calibration<br />
• Perform risk assessment for maintenance / calibration<br />
• Provide frontline support for technicians<br />
• Supervise maintenance / calibration work<br />
• Assess quality impact and release after maintenance<br />
• Assess equipment fit for purpose<br />
• Set-up maintenance for new equipment (incl. spare part needs)<br />
• Develop, monitor and improve KPI for maintenance & calibration<br />
• Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML)<br />
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request<br />
• Execute Change Requests<br />
• Investigate deviations (Root Cause Analysis)<br />
• Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)<br />
• Plan spare parts (order spare parts, manage master data, minimum order quantity, documentation)<br />
• Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements)<br />
<br />
Project Engineering & Control:<br />
• Identify technical solutions<br />
• Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification)<br />
• Develop project turn over plan<br />
• Perform new equipment FAT / SAT / inspections in project<br />
• Perform commission activities<br />
• Manage project deficiencies and deviations<br />
• Perform provisional and final project handover<br />
<br />
(Re-) Qualification:<br />
• Provide technical trouble shooting during PQ and validation<br />
• Develop periodic requalification plan<br />
• Execute periodic requalification plan<br />
<br />
Automation:<br />
• Develop & implement Coding / Recipes (DCS / Scada / PLC’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 />
• Improvement projects according to plan.<br />
• Maintenance and Calibrations plans approved and executed as planned.<br />
• No out of compliance calibrations.<br />
• Meet ratio preventive / corrective maintenance.<br />
• Equipment availability, reliability, effectiveness.<br />
• Mean time between failures (MTBF), mean time to recover (MTTR).<br />
• Spare part inventory.<br />
• Meet maintenance cost efficiency.<br />
• No critical findings in internal / external audits on qualifications.<br />
• Requalification plans approved and execute as planned, no major deviations, no overdue CAPAs.<br />
• 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>
Apply for this position
• Support internal and external audits<br />
• Lead or contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance)<br />
• Own the Training Curriculum for own Job Profile<br />
• Train operators and / or technician<br />
<br />
Maintenance & Calibration:<br />
• Establish maintenance & calibration plan content<br />
• Enter master data into CMMS (e.g. confirmation and technician time allocations)<br />
• Coordinate maintenance / calibration activities<br />
• Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)<br />
• Enter work orders into CMMS for maintenance / calibration<br />
• Develop method statement for maintenance / calibration<br />
• Perform risk assessment for maintenance / calibration<br />
• Provide frontline support for technicians<br />
• Supervise maintenance / calibration work<br />
• Assess quality impact and release after maintenance<br />
• Assess equipment fit for purpose<br />
• Set-up maintenance for new equipment (incl. spare part needs)<br />
• Develop, monitor and improve KPI for maintenance & calibration<br />
• Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML)<br />
• Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request<br />
• Execute Change Requests<br />
• Investigate deviations (Root Cause Analysis)<br />
• Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)<br />
• Plan spare parts (order spare parts, manage master data, minimum order quantity, documentation)<br />
• Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements)<br />
<br />
Project Engineering & Control:<br />
• Identify technical solutions<br />
• Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification)<br />
• Develop project turn over plan<br />
• Perform new equipment FAT / SAT / inspections in project<br />
• Perform commission activities<br />
• Manage project deficiencies and deviations<br />
• Perform provisional and final project handover<br />
<br />
(Re-) Qualification:<br />
• Provide technical trouble shooting during PQ and validation<br />
• Develop periodic requalification plan<br />
• Execute periodic requalification plan<br />
<br />
Automation:<br />
• Develop & implement Coding / Recipes (DCS / Scada / PLC’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 />
• Improvement projects according to plan.<br />
• Maintenance and Calibrations plans approved and executed as planned.<br />
• No out of compliance calibrations.<br />
• Meet ratio preventive / corrective maintenance.<br />
• Equipment availability, reliability, effectiveness.<br />
• Mean time between failures (MTBF), mean time to recover (MTTR).<br />
• Spare part inventory.<br />
• Meet maintenance cost efficiency.<br />
• No critical findings in internal / external audits on qualifications.<br />
• Requalification plans approved and execute as planned, no major deviations, no overdue CAPAs.<br />
• 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>