Job Description

Summary The C&Q engineer is responsible to perform commissioning & qualification for CAPEX project and routine maintenance such as Requalification and Periodic Review to ensure facilities/equipment/systems are maintained in a validated state. All C&Q activities are carried out in accordance to the global/site SOPs and the current version of GMP (Good Manufacturing Practice).The responsibilities of the C&Q Engineer includes but not limited to:Ensure commissioning and qualifications are in compliance with Quality Manual/Quality Modules/STDs/GOPs/site SOPs etc. Create & revise relevant SOPs for commissioning & qualification.Perform gap assessment due to revision of GOP and Work procedures etc.Annual update of Master Equipment Inventory (MEI) in COMOSDrafting of all required Commissioning & Qualification Deliverables (e.g URS, GMP-FRA, Concept Paper, Qualification Plan, Commissioning Test Plan, CTS, Design Qualification, TSIQ, TSOQ, TSPQ, CIP, SIP, Sterile Hold Studies, Qualification Release documents, Qualification Summary Reports etc etc)Perform Pre-Requisite checks for each Commissioning & Qualification Phases prior to protocol execution and support routine maintenance of the validated system status (e.g Periodic Review etc) thereafterDrafting of project documents (e.g Project Quality Plan, Master Qualification Plan, etc). Management of project deficiencies, project deviations, 1QEM (Deviation) etc and lead investigation (e.g root cause analysis) during commissioning & qualification. Perform project reviews/audit (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE etc)Engineering compliance oversight for approval of Equipment/Instrument Data Form & Spare parts material master change request form from all functions. Conduct regular compliance self-inspection within Engineering functionsPerform monthly checks on CSE PM01 & PM02 Work Orders in SAP to check for overdue and provide data for monthly SQC reporting.RequirementsDegree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalentFluent in English and proficient in local language.5 years of engineering project/commissioning /qualification /Compliance in PharmaExcellent technical knowledge with demonstrated ability to deliver safe, effective and fully compliant projects5 years of demonstrated leadership abilities, leading both internal and external team membersExcellent interdisciplinary knowledge (process, HVAC, automation, etc.)Outstanding GxP and regulatory knowledgeAdvanced HSE knowledgeSkills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

Novartis