Role Overview
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.
