Project CQV Manager-Biopharma

PES is an international services companyproviding Project Management, Construction Management, Commissioning &Qualification and Automation services to our clients in the pharmaceutical,nutritional and related sectors.

With offices across Europe, Asia and US, ourcore focus is on consistently delivering high-quality outcomes for ourmultinational clients.

This focus, and our people's experience indelivering consistent quality results for our clients over the past 20 yearshas been key to our success to date.

We are seeking a highly experienced CQV Project Lead to oversee and drive the successful completion of a large-scale biopharmaceutical greenfield project currently in the commissioning phase.

This role requires a senior industry professional with extensive experience managing complex CQV activities within major capital investment projects, ensuring alignment across all stakeholders, maintaining project schedules, and leading teams through peak commissioning and qualification activities.

Key Responsibilities

• Lead and manage the full CQV lifecycle for a large-scale biopharmaceutical manufacturing project.
• Drive project execution during the critical commissioning and qualification phase to ensure on-time project delivery.
• Coordinate cross-functional stakeholders including Engineering, Operations, Quality, Automation, Validation, and external vendors/contractors.
• Develop and oversee CQV strategies, execution plans, schedules, and resource planning.
• Ensure all commissioning, qualification, and validation activities comply with GMP, regulatory, and client requirements.
• Provide leadership and direction to CQV teams across multiple workstreams and project areas.
• Identify project risks, bottlenecks, and delays, and implement mitigation plans proactively.
• Lead project governance meetings, stakeholder reviews, and progress reporting.
• Support readiness activities for operational handover and regulatory inspections.

Requirements

• Minimum 30 years of experience in Commissioning, Qualification, and Validation (CQV) within the biopharmaceutical industry.
• Proven experience leading CQV activities for large-scale greenfield biopharma manufacturing facilities.
• Strong experience managing all phases of CQV, from planning and strategy through execution and project closeout.
• Demonstrated experience working on major capital investment projects exceeding USD 500 million.
• Extensive experience leading multidisciplinary teams in high-pressure project environments.
• Strong stakeholder management and leadership capabilities with the ability to align teams and drive execution.
• Deep understanding of GMP, FDA, EMA, and global regulatory expectations for biopharmaceutical facilities.
• Experience managing complex project schedules and delivering projects within aggressive timelines.
• Excellent communication, leadership, and problem-solving skills.

Preferred Background

• Experience in biologics, vaccines, cell & gene therapy, or sterile manufacturing facilities.
• Previous experience acting as client-side CQV lead or overall CQV program lead on mega projects.
• Familiarity with digital CQV systems and integrated project delivery models is an advantage.

Key Success Factors

• Ability to stabilize and drive project execution during peak commissioning activities.
• Strong leadership presence capable of coordinating multiple stakeholders and contractors.
• Proven track record of delivering large-scale projects successfully and on schedule.

If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Sruthi Srikanth ([email protected]).

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We are an equal opportunity employer committed to creating an inclusive and diverse workplace. We welcome applications from qualified candidates of all backgrounds, experiences, and perspectives. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, gender, age, nationality, disability, sexual orientation, or any other protected characteristic.