Experience

Process Engineering Specialists

• Singapore
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior CQV Engineer

  • Jul 2022 - Present



PSC Biotech Corporation

• United States
• Biotechnology
• 300 - 400 Employee

• Senior Validation Engineer

  • Jan 2022 - May 2022

• Validation Engineer

  • Jul 2019 - May 2022



MSD

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project/ CSV Engineer

  • Mar 2020 - Mar 2022

  Project CSV Engineer for Enterprise Resiliency Modernisation Data Integrity (ERMD) - Lab Equipment: HPLC, UHPLC and GC Systems) • Responsible to prepare & review related lifecycle and/ or validation documentation; qualification, retirement and vendor protocols (i.e. MSD IOQ, RTM, CRS, RS, CS, Vendor IOQ (EQP/ SQT), Memo) and summary reports etc. • Raised Global Change Management (GCM) Records for the system related changes through TrackWise system; not limited to creating relevant tasks (PET/ TCT/ PRT) and performing impact assessment with respective SMEs. • Ensuring validation documents progression aligned with project schedule, from preparation to approval/ closure. • Coordinate with the vendors (i.e. Agilent and Waters) on equipment and systems related matters such as Vendor IOQ, PM and Calibration, etc. • Liaising with the user team (i.e. Tablet/ Biotech/ API Lab) on any relevant matters pertaining to the system or equipment, i.e. Timeline and Planning, Equipment Selection, PM Schedule, End Calibration, SOP/ Job Aids/ WI (including training and communication) etc. • Perform field activities for retirement and/ or qualification; i.e. not limited to verifying LACE/S, verifying and compiling qualification packages to be archived, verifying PM and End Calibration performed, equipment is registered or removed in SAP/ MODA, protocol execution by vendor, execution of MSD IOQ protocol accordingly and ensuring deviation generation are aligned with the quality standard and transparent to the team. • Responsible for the system handover including documentation (i.e. Qualification Assurance Summary Report (QASR) and Release Authorization Notice (RAN)) to the user (laboratories). • Interdisciplinary liaising on daily basis (Business Unit, Quality Unit, Technical Unit, Vendors and User - laboratories). • Managing and aligning the workload of the equipment and documentation preparation responsibility within the team, involved in the tier and team meeting. Show less



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Validation Engineer

  • Jul 2019 - Nov 2019

  • Responsible to prepare & review related lifecycle and/ or validation documentation; Impact Assessment, Risk Assessment (inclusive FMEA), Isometrics & P&ID’s, Turn Over Package (TOP), validation and commissioning protocols (i.e. IOQ, OQ, PQ (Pre-FLTS), Commissioning) and summary reports etc. • Ensuring validation documents progression aligned with project schedule, from preparation to approval/ closure. Perform field activities, verifying computer-based systems are operating accordingly & ensuring deviation generation are aligned with the schedule and transparent to the team. • Managing & performing validation documentation, activities & executions: o Commissioning Execution – Pre-requisite checks, P&ID verification & walkdown, equipment spares, calibration, and PM verification, APC/ I/O/ Alarms and Interlocks verification, Start-up & Shutdown test, equipment/ process operation (testing and inspection of the samples according to sampling plan (includes grammage and formation) and acceptance criteria (CQA/ CPP), etc. o IOQ & OQ Execution – Pre-requisite checks, P&ID verification & walkdown, calibration, SOP verification, machinability, visual and inspection test, equipment/ process operation (testing and inspection of the samples according to sampling plan (includes grammage and formation) and acceptance criteria (CQA/ CPP), etc. o Pre-FLTS Execution – Manufacturing scale-up of equipment/ process operation (testing and inspection of the samples according to sampling plan (includes grammage and formation) and acceptance criteria (CQA/ CPP), etc. • Raised Change Control Record (CCR) for the project, process or system related changes through M-Files system. • Interdisciplinary liaising on daily basis (Automation, Quality, Engineering, Manufacturing, Vendors and User team). • Responsible for the system handover including documentation to the user organization. Show less



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Validation Engineer

  • Sep 2018 - Jun 2019

  Validation Engineer (Process Agility Project, PDS) • Responsible to prepare & review related lifecycle and validation documentation; System Impact Assessment (SIA), Critical Impact Assessment (CIA), Instrumentation Critical Assessment (ICA), Isometrics & P&ID’s, Turn Over Package (TOP), validation protocols (i.e. DQ, IQ, OQ, PQ, CQP) and summary reports etc. • Ensuring validation documents progression aligned with project schedule, from preparation to approval/ closure. Perform field activities, verifying computer-based systems are operating accordingly & ensuring deviation generation are aligned with the schedule and transparent to the team. • Managing & performing validation documentation, activities & executions: o IQ Execution – Pre-requisite checks, P&ID & slopes walkdown, Isometrics verification & redlining, calibration, etc. o OQ & PQ Execution – SOP Verification, recipe parameters verification & tuning, CIP, SIP, Harvest Operation etc. • Interdisciplinary liaising daily (Automation, MSAT – Facility Engineering, QVCSV, Manufacturing, and User team). • Responsible for the system handover including documentation to the user organization. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Qualification Engineer, QA/QC Engineer, CIP CQ Documentation Specialist

  • Jun 2017 - Aug 2018

  NOVARTIS BIOPHARMS OPS Tuas, Singapore | Project: CIP120 Remediation Project (Phase 1) & Phase 2 Project Qualification Engineer, QA/QC Engineer, CIP CQ Documentation Specialist | GPE/ Project – CIP ‐ Responsible to prepare & review related C&Q documentation using User Requirement Specification (URS), Sensor Risk Assessment (SRA), Isometrics & P&ID’s, Commissioning Turn Over Dossier (CTOD) & Vendor Turn Over Dossier (VTOD), C&Q protocols (i.e. TSQ, TSIQ, TSOQ, CTP, CTS) etc. ‐ Ensuring C&Q documents progression aligned with project schedule, from preparation to closure. Manage field activities (generate permits, support daily coordination and field activities) & project deviations are aligned with the schedule and transparent to the management team. ‐ Interdisciplinary liaising on a daily basis (Automation, Site Engineering, QA/QMC, E&I, Construction Contractor and User team). ‐ Managing all documentation drawn up by suppliers/contractors used for C&Q ‐ Communicate & liaise with multiple stakeholders for any field & documentation changes required. ‐ Raised Project Change Control Management (CRNs) for the project, process or system related changes. ‐ Generated Pre‐Requisites and responsible to drive and close related COMOS tasks. ‐ Responsible for the C&Q handover including documentation to the user organization. ‐ Assist the team lead on scheduling and managing the Go/ No Go meeting for the OQ Shakedown and Execution. ‐ Supported field in shaking down hot loop checks, EM path verification, OP review, UP review. ‐ Assist the team for CIP shakedown for USP/DSP related EGs. Show less



No deviation

• Singapore
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance & Validation Engineer

  • Nov 2015 - Aug 2018

  Clients: Novartis, AbbVie, GSK Clients: Novartis, AbbVie, GSK



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Commissioning & Qualification Engineer/ Document Preparer

  • Apr 2016 - Jun 2017

  ABBVIE BIOLOGICS Tuas, Singapore | Project: AbbVie Project Genesis Commissioning & Qualification Engineer/ Document Preparer | Project – Central Services & Clean Utilities Responsible to prepare & review related C&Q documentation for Process Central Services (i.e. CIP systems, Buffer systems, Media Preparation etc.) & Clean Utilities Systems (i.e. WFI, Clean Steam, Nitrogen, Oxygen etc.) ‐ User Requirement Specification (URS), Design Qualification & Traceability Matrix (DQTM), System Level impact Assessment (SLIA) & Critical Level Instrument Assessment (CLIA), Vendor Turn Over Dossier (VTOD), C&Q protocol (i.e. IQ, IV, OQ, OV, IOQ) etc. ‐ Managing & performing C&Q documentation, activities & executions; o Pre‐requisite checks, Hot loop checks, P&ID walkdown, Isometrics verification & redlining, Punch list items generation & tracking, o EM Verification, recipe testing, parameter tuning etc. o Level strapping, filter commissioning, pressure control, internal inspection, vessel jacket commissioning, assisted with instrument calibration etc. ‐ Involved directly in Project Change Control Management – P&ID changes, process specification & parameters changes etc. ‐ Coordinate & communicate with various team; commissioning, qualification, automation, user and QA for C&Q related matters. ‐ Assist the lead & team in daily C&Q activities (whiteboard, changeover meetings etc.), related safety requirements (Safety work method statement (SWMS), Lock out Tag out (LOTO), Pre‐Startup Safety Review (PSSR) etc.) and ensure effective communication across various process teams. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Process Development Engineer

  • Nov 2015 - Mar 2016

  GSK Vaccines Tuas, Singapore | Project: Vaccines Process Development Engineer | Process Excellence In‐charged on project management, (inclusive of scheduling, CQV documentation ‐ SLIA, Critical Instrument Assessment (CIA), protocol, URS) for over 50 equipment i.e. Chromatography system (Lab and Pilot scale), coupling reactor, Laminar Air Flow, etc. GSK Vaccines Tuas, Singapore | Project: Vaccines Process Development Engineer | Process Excellence In‐charged on project management, (inclusive of scheduling, CQV documentation ‐ SLIA, Critical Instrument Assessment (CIA), protocol, URS) for over 50 equipment i.e. Chromatography system (Lab and Pilot scale), coupling reactor, Laminar Air Flow, etc.



Biocon

• India
• Biotechnology Research
• 700 & Above Employee

• Quality Assurance Engineer

  • Mar 2014 - Nov 2015

  Biocon Sdn. Bhd. Johor, Malaysia | Project: Insulin Quality Assurance Engineer | Engineering & Maintenance (E&M) ‐ Preparing & performing validation (CQV) associated with engineering related systems & processes. ‐ In charged of documentation management ‐ document control activities (inclusive procedures, protocol, report, technical documents, drawings, and commercial correspondence etc.) related to QMS, EHS and E&M System are available and updated. ‐ Managing the training subdivision; conduct trainings and maintaining training documentations (training matrix & schedule). ‐ Established an efficient E&M management system for the plant use (i.e. Preventive Maintenance Planning & Scheduling, Breakdown Maintenance system, Part and Spare Management). ‐ Involved in Continuous Improvement (CI) projects, engineering study, & activities. ‐ Involved directly with various audits & ensuring all related documentation are in compliance. Show less



Alcon

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• QA Engineer

  • Dec 2011 - Mar 2014

  CIBA VISION, Johor, Malaysia | Project: Lotrafilcon B (Air Optix Aqua) Quality Assurance Engineer | Quality Engineering ‐ Project Leader: In‐charge with coordinating & conducting plant wide FMEA Assessment. ‐ Preparing & performing validation (CQV) associated with new product or process implementation. ‐ Ensure quality matters related to customer complaints are analyse, investigate (i.e. assignable root cause), implement (i.e. CAPA) and closed with effectiveness check in timely manner. ‐ Involved in CI activities by applying IQP (Innovation, Quality, & Productivity) Tools & conducting engineering study. ‐ Create and maintain company quality documentation (quality manuals, procedures etc.). Show less



Venture Corporation Limited

• Singapore
• Appliances, Electrical, and Electronics Manufacturing
• 700 & Above Employee

• QA Engineer

  • May 2010 - Nov 2011

  VENTURE, Johor, Malaysia | Project: Ulysses, Troja, Contax Quality Assurance Engineer | Quality Assurance ‐ In charge & managed QA/QC subordinates and ensured that product quality is up customers’ satisfaction. ‐ Involved directly with clients & third party in regard with quality & production related matters. ‐ Ensure respective departments complies with the quality procedures, policies & guidelines. ‐ Provide related quality documentation to clients and management team. - Dealing with weekly internal and monthly external audits. Show less