Design Manager-CQV is responsible for leading and delivering end-to-end commissioning, qualification, and validation (CQV) programs for pharmaceutical, biotechnology, and medical device projects. This role combines technical subject matter expertise with project leadership, ensuring compliance with global regulatory standards while meeting project timelines, quality, and budget targets.
The role requires deep experience in GxP environments, risk-based validation, and facility/equipment qualification, along with strong stakeholder and team management skills. The role will require an experienced, energetic, and committed CQV person with broad experience in C&Q, particularly biopharmaceuticals and having experience of >15 years. The person should have experience of leading CQV engineers for big projects and managing the C&Q documentation and execution lifecycle, from SLIA generation through to OQ/ PQ completion. They will work closely with cross-functional teams, including engineering, quality assurance, and manufacturing, to support the successful delivery of projects.
- Lead and execute CQV activities across multiple CQV projects, ensuring timely execution and compliance with industry regulations.
- Act as an SME for CQV having technical authority for systems such as process equipments, process utilities, automation, HVAC and controlled environments.
- Manage multi-disciplinary teams including CQV engineers, vendors, and contractors.
- Serve as the primary CQV interface with clients, design teams and Quality & regulatory teams.
- Track project deliverables, budgets, risks, and timelines and provide regular project updates and status reports to stakeholders.
- Drive decision-making and resolve escalations with engineering team and client.
- Involve in GMP review of layouts and systems and ensure CQV requirements are embedded early in the design lifecycle.
- Review P&IDs, layouts, URS, FS/DS, equipment specifications and vendor documentation.
- Mentor and guide CQV engineers and junior staff.
- Establish best practices, templates, and standard methodologies.
- Drive continuous improvement and knowledge sharing within the team.
- Prepare C&Q plans in line with the strategic goals of the client and manage timely and compliant delivery of the plan.
- Ensure all commissioning and qualification procedures are implemented and adhered to at office and at site level.
- Complete the development, review and execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports.
- Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM) and meets data integrity (ALOCOA+) principles.
Well versed in commissioning and qualifying CIP & SIP systems
