CQV Lead

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

Job summary

Coalesce Management Consulting is seeking an experienced C&Q Lead for a 5kL GMP-regulated pharmaceutical manufacturing project. You will oversee commissioning, qualification and validation activities, coordinate protocols and teams, and ensure documentation is complete and inspected-ready.

The ideal candidate has 6–8 years of CQV experience, strong technical-writing skills, and the ability to work across Engineering, Manufacturing, Quality, and Vendors in a fast-paced environment.

Qualifications

• 6–8 years of commissioning, qualification, or validation experience within GMP-regulated manufacturing.
• Hands-on experience with CQV activities in pharma/biotech settings.
• Working knowledge of cleaning-validation principles and documentation.
• Strong technical-writing, planning and stakeholder-management skills.
• Ability to lead and coordinate validation teams independently.

Responsibilities

• Lead and oversee commissioning, qualification, and validation activities for the 5kL manufacturing project.
• Develop, review, and approve validation lifecycle documentation including plans, URS, risk assessments, DQ/IQ/OQ/PQ protocols, and summary reports.
• Ensure C&Q activities are planned and executed per procedures, GMP requirements, data-integrity principles, and timelines.
• Review engineering docs such as P&IDs, equipment specifications, and vendor packages.
• Coordinate protocol execution and guide validation engineers, contractors, vendors, and other project personnel.
• Provide oversight of equipment and manufacturing-system qualification, including utilities and automated functions.
• Support cleaning-validation activities, including protocol review, execution oversight, deviation assessment, and reporting.
• Review qualification discrepancies, protocol deviations, test failures, and ensure investigation and resolution.
• Provide validation input into change controls, risk evaluations, and system-release decisions.
• Monitor progress, identify compliance or scheduling risks, and communicate issues to stakeholders.
• Ensure validation documentation is complete, traceable, inspection-ready, and closed on time.
• Support additional validation requests based on project/site requirements.
• Assist with internal audits, regulatory inspections, and inspection-readiness activities.

Job description

The C&Q Lead will provide validation oversight and hands-on support for a 5kL manufacturing project within a GMP-regulated pharmaceutical environment. The role will lead and coordinate commissioning and qualification activities, support cleaning validation where required, and provide validation assistance for other ad hoc site projects.

This position is suited to an experienced C&Q professional who can independently manage validation deliverables, guide project team members, and work closely with Engineering, Manufacturing, Quality, Automation, vendors, and other stakeholders.

Key Responsibilities

• Lead and oversee commissioning, qualification, and validation activities for the 5kL manufacturing project.
• Develop, review, and approve validation lifecycle documentation, including validation plans, User Requirement Specifications, risk assessments, DQ, IQ, OQ, PQ protocols, and summary reports.
• Ensure C&Q 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

Candidate Requirements

• Degree in Engineering, Pharmaceutical Science, Biotechnology, Life Sciences, or a related discipline.
• Approximately 6-8 years of relevant commissioning, qualification, or validation experience within the pharmaceutical, biotechnology, or another GMP-regulated manufacturing environment.
• Strong hands-on experience with equipment and manufacturing CQV activities.
• Working knowledge of cleaning-validation principles and documentation.
• Sound understanding of the validation lifecycle, including risk assessments, DQ, IQ, OQ, PQ, deviations, change control, and final reporting.
• Experience providing technical leadership, coordinating project resources, or guiding validation team members is preferred.
• Able to review engineering documentation such as P&IDs, equipment specifications, and vendor packages.
• Strong technical-writing, problem-solving, planning, and stakeholder-management skills.
• Able to work independently, manage multiple priorities, and provide practical validation support in a fast-paced project environment.