CQV Lead Engineer

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