ZAMRI NGATMAN
Commissioning, Qualification & Validation (CQV) Engineer
Kangkar Pulai,JB
Summary
CQV Engineer delivering commissioning, qualification, and validation for GMP manufacturing, laboratory, and automation systems on numerous projects for different clients in Singapore and Malaysia, with most projects completed within timeline, including qualification and validation protocols for more than 20 systems per project. Executes URS, DQ, IQ, OQ, PQ, risk assessments, and closes more than 20 change controls per month across cGMP and Data Integrity requirements. Supports decommissioning, control-system modifications, and vendor execution on tightly managed project timelines.
Overview
13
13
years of professional experience
Work History
CQV Engineer
Coalesce Management Consulting, Pte Ltd
Tuas, Singapore
06.2022 - Current
- Contributed to Pharm South (MSD) decommissioning project, facilitating retirement of local equipment control systems and divisional systems.
- Participated in LCM project for South Compounding Control System Modification, QDOC execution, PUW Control System Modification, and GMP BAS Control System Modification.
- Involved in ERMD project for the Qualification and Decommissioning of Laboratory analytical instruments (Gas Chromatography and HPLC)
- Developed and executed retirement protocol for type B1, B2 and C Lab equipment.
- Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.
- Involved in Pharm South (MSD) Decommissioning Project on the retirement of local equipment control systems and divisional systems.
- Involves in ERMD project for the Qualification and Decommissioning of Laboratory analytical instruments (Gas Chromatography and HPLC)
- Developed and executed retirement protocol for type B1, B2 and C Lab equipments.
- Utilizing Kneats and QDocs (VeevaVault) on preparing protocol and Change Control.
- Project Site: MSD (Tuas, Singapore)
CQV Engineer
Hyde Engineering and Consulting
12.2021 - 06.2022
- Developed User Requirement Specifications (URS) for Kanban, Gowning, Laboratory, and Support HVAC systems, ensuring alignment with IFC drawings and technical specifications.
- Performed System Risk Assessments (SRA) for HVAC Building Management Systems (BMS) and Environmental Monitoring Systems (EMS), identifying potential risks and enhancing system reliability.
- Developed the Risk Assessment Matrix for the Early Access phase and generated the RACI Matrix for the Trinity Dexcom project.
- Verified and reviewed Commissioning Protocols for Early Access and Trinity project scopes, ensuring compliance with project requirements and standards.
- Project Site: Dexcom (Penang, Malaysia)
CQV Engineer
Hyde Engineering and Consulting
04.2021 - 12.2021
- Led CQV activities for microbiology laboratory equipment to ensure compliance and functionality.
- Drafted design qualification (DQ), system level impact assessment (SLIA), component level impact assessment (CLIA), 21 CFR Part 11 assessments, and IOQ protocols for EMS to support project validation efforts.
- Developed traceability matrices (RTM) for integrated BMS and EMS infrastructure to enhance system integration and compliance.
- Evaluated and approved vendor static and dynamic test protocols.
- Project Site: Oncogen Pharma (Malaysia)
Validation Engineer
Coalesce Management Consulting Pte. Ltd.
03.2020 - 03.2021
- Contributed to Data Integrity (DI) Remediation activities ensuring compliance during retirement and decommissioning of Type A, B1, B2, and C laboratory equipment.
- Authored and executed Global Change Management (GCM) records within TrackWise.
- Enhanced Configuration Specification (CRS) and Requirement Traceability Matrix (RTM) documentation for Type C lab equipment under the MIDAS CDS Platform to improve accuracy and usability.
- Streamlined SOPs and Work Instructions (WIs) for Type C equipment utilizing the QualityDocs system to ensure clarity and ease of use.
- Client Site: MSD Singapore Pte. Ltd.
Validation Engineer
Coalesce Management Consulting Pte. Ltd.
09.2019 - 02.2020
- Provided validation guidance for Moonstone Project (Alcon Divestment Initiative), ensuring alignment with global regulatory frameworks and enhancing project execution.
- Finalized Project Assessments (PA) and Validation Plans (VP) by reviewing "One Document Concept" protocols for executive approval.
- Developed Installation Qualification (IQ) and Process Validation (PV) protocols, including Hold Time Studies for HPMC Pre-Mixing Tank modification.
- Client Site: Alcon Manufacturing & Logistics Pte. Ltd.
Project, Commissioning & Qualification Engineer
Project Engineer Specialist (PES)
12.2017 - 04.2019
- Authored and executed DQ, IQ, and OQ documentation for the facility's Environmental Management System (EMS).
- Authored and executed DQ, IQ, and OQ documentation to ensure compliance and operational readiness of Environmental Management System (EMS).
- Reviewed and updated URS, FDS, HDS, and SDS documentation for Siemens-based automation systems (TIA Portal V14, WinCC V7.4).
- Managed Change Controls and Deviations during PLC IQ/OQ execution across filling and packaging lines.
- Managed Change Controls and Deviations to facilitate smooth PLC IQ/OQ execution across filling and packaging lines.
- Singapore Pte. Ltd.
- Client Site: Mundipharma Pte. Ltd.
Project, Commissioning & Qualification Engineer
Project Engineer Specialist (PES)
03.2017 - 11.2017
- Executed Automation I/O Qualification protocols for the DeltaV Environmental Monitoring System, delivering final Summary Reports.
- Executed CQV and CIP/SIP validation for process vessels, resolving all associated commissioning documentation.
- Addressed deviations and managed system change controls throughout the automation qualification lifecycle.
- Performed Cleaning Validation for upstream bioreactor process vessels.
Production Executive (Upstream)
Biocon Malaysia Sdn. Bhd.
09.2013 - 03.2017
- Completed an intensive 5-month international technical and cGMP training program at Biocon Ltd. (Bangalore, India).
- Operated fully automated submerged fermentation plants driven by DeltaV DCS.
- Executed sterility tests, Stage I/II batch processing, development/consistency batches, and process validation for Insulin Glargine (rDNA origin) and Human Insulin manufacturing.
- Executed sterility tests, Stage I/II batch processing, and process validation for Insulin Glargine (rDNA origin) and Human Insulin manufacturing, ensuring compliance with cGMP standards.
- Led Sterilization-In-Place (SIP) and Cleaning Validation runs for all bioreactors, supporting transition from early stage qualification to successful commercial launch.
- Authored standard operating procedures (SOPs) and Equipment Operating Procedures (EOPs) for Bioreactors and associated equipment, enhancing operational consistency and compliance.
- Nusajaya
Education
Bachelor of Applied Science (Hons) - Industrial Biotechnology
University Malaysia Pahang
01-2013
Skills
CSV documentation
URS development
IQ/OQ/PQ protocols
Risk assessments
Change control
Validation master planning
Traceability matrix development
SOP authoring
Protocol execution
Deviation management
GxP documentation control
Vendor coordination
GMP compliance
Regulatory documentation review
Commissioning support
Equipment decommissioning
Timeline
CQV Engineer
Coalesce Management Consulting, Pte Ltd
06.2022 - Current
CQV Engineer
Hyde Engineering and Consulting
12.2021 - 06.2022
CQV Engineer
Hyde Engineering and Consulting
04.2021 - 12.2021
Validation Engineer
Coalesce Management Consulting Pte. Ltd.
03.2020 - 03.2021
Validation Engineer
Coalesce Management Consulting Pte. Ltd.
09.2019 - 02.2020
Project, Commissioning & Qualification Engineer
Project Engineer Specialist (PES)
12.2017 - 04.2019
Project, Commissioning & Qualification Engineer
Project Engineer Specialist (PES)
03.2017 - 11.2017
Production Executive (Upstream)
Biocon Malaysia Sdn. Bhd.
09.2013 - 03.2017
Bachelor of Applied Science (Hons) - Industrial Biotechnology
University Malaysia Pahang