CQV Lead: GMP Validation & Commissioning Specialist

Coalesce Management Consulting; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Coalesce Management Consulting seeks a C&Q Lead to provide validation oversight and hands-on support for a 5kL manufacturing project within a GMP-regulated pharmaceutical environment.

The role requires independent management of validation deliverables, guiding project team members, and close collaboration with Engineering, Manufacturing, Quality, Automation, vendors, and other stakeholders to ensure on-time delivery.

Qualifications

• Degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences, or related discipline.
• 6–8 years of commissioning, qualification, or validation experience in GMP manufacturing.
• Hands-on CQV experience with equipment and manufacturing.
• Knowledge of validation lifecycle: DQ, IQ, OQ, PQ, deviations, change control, and final reporting.
• Ability to lead and coordinate validation team and communicate with stakeholders.

Responsibilities

• Lead commissioning, qualification, and validation activities for the 5kL manufacturing project.
• Develop, review, and approve validation lifecycle documentation, including validation plans, URS, risk assessments, DQ, IQ, OQ, PQ protocols, and summary reports.
• Ensure CQV activities are planned and executed in accordance with approved procedures, GMP requirements, data-integrity principles, and project timelines.
• Review engineering designs, equipment specifications, P&IDs, vendor documentation, commissioning records, calibration certificates, and turnover packages.
• Coordinate protocol execution and provide technical guidance to validation engineers, contractors, vendors, and other project personnel.
• Provide oversight of equipment and manufacturing-system qualification, including associated utilities and automated functions where applicable.
• Support cleaning-validation activities, including protocol review, execution oversight, deviation assessment, and final reporting.
• Review and assess qualification discrepancies, protocol deviations, test failures, and technical issues, ensuring appropriate investigation and resolution.
• Provide validation input into project change controls, impact assessments, risk evaluations, and system-release decisions.
• Monitor project progress, identify compliance or scheduling risks, and communicate issues and required actions to relevant stakeholders.
• Ensure validation documentation is complete, traceable, inspection-ready, and closed within the required timelines.
• Support additional validation and qualification requests based on project and site requirements.
• Assist with internal audits, regulatory inspections, and inspection-readiness activities where required

Skills

CQV experience

Project leadership

Documentation skills

GMP knowledge

Technical writing

Education

Engineering / life sciences degree

Job description

Coalesce Management Consulting seeks a C&Q Lead to provide validation oversight and hands-on support for a 5kL manufacturing project within a GMP-regulated pharmaceutical environment.

The role requires independent management of validation deliverables, guiding project team members, and close collaboration with Engineering, Manufacturing, Quality, Automation, vendors, and other stakeholders to ensure on-time delivery.