- Singapore
Full Time CQV Lead Engineer Jobs, salary up to SGD 13,500 in ANTER CONSULTING PTE. LTD. - Ricebowl
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Job Description
Responsibilities
About the Role
Anter Consulting is seeking an experienced CQV Lead Engineer specialising in temperature mapping to support a leading global pharmaceutical manufacturer in Singapore.
This role leads the temperature mapping and thermal validation workstream across controlled temperature units, storage areas, and thermal process equipment. The successful candidate will own the technical approach end to end — from mapping strategy and protocol authoring through field execution, data analysis, and final report approval — while providing technical leadership to a team of CQV engineers and technicians.
Key Responsibilities
Temperature Mapping Delivery
Develop the temperature mapping strategy and approach for controlled temperature units, storage areas, and thermal equipment, including sensor quantity, placement rationale, and study duration
Author, review, and approve temperature mapping protocols and reports for empty and loaded chamber studies
Lead field execution of mapping studies, including sensor deployment, pre- and post-calibration verification, and data retrieval
Perform worst-case identification, hot spot and cold spot determination, and define permanent monitoring sensor locations based on mapping outcomes
Execute supporting studies including open door recovery, power failure recovery, and seasonal or periodic re-mapping
Analyse mapping data, including Mean Kinetic Temperature calculations where applicable, and present conclusions to stakeholders
Equipment and Facility Scope
Controlled temperature units — cold rooms, freezers, refrigerators, incubators, and stability chambers
Warehouse and storage areas, including ambient and controlled ambient spaces
Thermal process equipment such as autoclaves, depyrogenation ovens and tunnels, and lyophilisers
Transport and shipping lane qualification where in scope
Technical Leadership
Provide technical leadership and direction to a team of CQV engineers and technicians executing mapping activities
Review and approve work produced by team members, ensuring technical accuracy and GMP compliance
Plan and schedule mapping activities against the overall project programme, coordinating access with operations and facilities
Act as the technical point of contact for the client on all temperature mapping matters
Mentor junior engineers and build mapping capability within the team
Compliance and Documentation
Ensure all activities comply with GMP, GDP, and data integrity requirements (ALCOA+)
Manage deviations, discrepancies, and out-of-specification results arising during execution, including investigation and resolution
Support change control and periodic requalification programmes for mapped systems
Prepare documentation to inspection-ready standards and support regulatory and client audits
Maintain calibration status and traceability for all mapping equipment
Key Requirements
Degree in Engineering, Life Sciences, or a related discipline
Minimum 8 years of CQV experience within pharmaceutical, biotechnology, or GMP-regulated manufacturing, with at least 3 years focused on temperature mapping and thermal validation
Demonstrated experience leading temperature mapping studies end to end — strategy, protocol authoring, execution, data analysis, and report approval
Hands-on experience with validation data logging systems such as Kaye, Ellab, Vaisala, or equivalent
Strong working knowledge of thermal validation principles including sensor placement rationale, worst-case determination, Mean Kinetic Temperature, and F0 where applicable
Familiarity with relevant guidance including EU GMP Annex 15, GDP requirements, WHO and USP guidance on storage area qualification
Experience managing deviations, discrepancies, and out-of-specification investigations
Proven ability to lead and technically direct a team of engineers or technicians
Strong documentation and communication skills, with the ability to work across operations, quality, engineering, and facilities teams
Comfortable working on site, including occasional out-of-hours execution where production schedules require
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.
Anter Consulting is seeking an experienced CQV Lead Engineer specialising in temperature mapping to support a leading global pharmaceutical manufacturer in Singapore.
This role leads the temperature mapping and thermal validation workstream across controlled temperature units, storage areas, and thermal process equipment. The successful candidate will own the technical approach end to end — from mapping strategy and protocol authoring through field execution, data analysis, and final report approval — while providing technical leadership to a team of CQV engineers and technicians.
Key Responsibilities
Temperature Mapping Delivery
Develop the temperature mapping strategy and approach for controlled temperature units, storage areas, and thermal equipment, including sensor quantity, placement rationale, and study duration
Author, review, and approve temperature mapping protocols and reports for empty and loaded chamber studies
Lead field execution of mapping studies, including sensor deployment, pre- and post-calibration verification, and data retrieval
Perform worst-case identification, hot spot and cold spot determination, and define permanent monitoring sensor locations based on mapping outcomes
Execute supporting studies including open door recovery, power failure recovery, and seasonal or periodic re-mapping
Analyse mapping data, including Mean Kinetic Temperature calculations where applicable, and present conclusions to stakeholders
Equipment and Facility Scope
Controlled temperature units — cold rooms, freezers, refrigerators, incubators, and stability chambers
Warehouse and storage areas, including ambient and controlled ambient spaces
Thermal process equipment such as autoclaves, depyrogenation ovens and tunnels, and lyophilisers
Transport and shipping lane qualification where in scope
Technical Leadership
Provide technical leadership and direction to a team of CQV engineers and technicians executing mapping activities
Review and approve work produced by team members, ensuring technical accuracy and GMP compliance
Plan and schedule mapping activities against the overall project programme, coordinating access with operations and facilities
Act as the technical point of contact for the client on all temperature mapping matters
Mentor junior engineers and build mapping capability within the team
Compliance and Documentation
Ensure all activities comply with GMP, GDP, and data integrity requirements (ALCOA+)
Manage deviations, discrepancies, and out-of-specification results arising during execution, including investigation and resolution
Support change control and periodic requalification programmes for mapped systems
Prepare documentation to inspection-ready standards and support regulatory and client audits
Maintain calibration status and traceability for all mapping equipment
Key Requirements
Degree in Engineering, Life Sciences, or a related discipline
Minimum 8 years of CQV experience within pharmaceutical, biotechnology, or GMP-regulated manufacturing, with at least 3 years focused on temperature mapping and thermal validation
Demonstrated experience leading temperature mapping studies end to end — strategy, protocol authoring, execution, data analysis, and report approval
Hands-on experience with validation data logging systems such as Kaye, Ellab, Vaisala, or equivalent
Strong working knowledge of thermal validation principles including sensor placement rationale, worst-case determination, Mean Kinetic Temperature, and F0 where applicable
Familiarity with relevant guidance including EU GMP Annex 15, GDP requirements, WHO and USP guidance on storage area qualification
Experience managing deviations, discrepancies, and out-of-specification investigations
Proven ability to lead and technically direct a team of engineers or technicians
Strong documentation and communication skills, with the ability to work across operations, quality, engineering, and facilities teams
Comfortable working on site, including occasional out-of-hours execution where production schedules require
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.
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