Lead C&Q Engineer

CAI; Deutschland; On-site; EUR 90,000 - 130,000; Full time

Job summary

CAI seeks an experienced Lead C&Q Engineer - HVAC to join a high-profile pharmaceutical project team in Europe. You will lead commissioning and qualification for HVAC, cleanroom, and facility systems, interfacing with design, construction, automation, quality and operations.

The role requires 10+ years of CQV experience in regulated industries, strong HVAC/cleanroom expertise, and proven ability to deliver in line with GMP and project schedules; EU eligibility and Kneat knowledge are desirable.

Qualifications

• Degree in Engineering or related technical discipline.
• 10+ years' commissioning, qualification or validation experience in pharmaceutical/biotech/regulated industries.
• Strong HVAC and cleanroom qualification experience.
• Experience supporting large capital projects from design through handover.
• Knowledge of ASTM E2500 and risk-based CQV methodologies.
• Experience with electronic validation systems such as Kneat is desirable.
• Excellent stakeholder management and communication skills.
• Eligible to work within the EU.

Responsibilities

• Lead commissioning and qualification for HVAC, cleanroom and facility systems.
• Review design documentation including P&IDs, specifications, drawings, equipment schedules and design packages.
• Develop and execute CQV deliverables including DQs, risk assessments, traceability matrices, FATs, SATs, commissioning protocols and qualification protocols.
• Coordinate field walkdowns, construction readiness reviews and turnover package assessments.
• Drive punch list resolution and commissioning readiness activities.
• Support startup, energization and operational verification activities.
• Manage vendor interactions and oversee HVAC system testing and balancing activities.
• Ensure documentation complies with GMP requirements and site procedures.
• Provide leadership and mentoring to CQV engineers and project teams.
• Collaborate with cross-functional stakeholders to deliver systems safely, compliantly and on schedule.

Skills

Lead CQV activities

Stakeholder management

Communication skills

GMP awareness

Education

Degree in Engineering or related discipline

Tools

Kneat

Job description

CAI was established in 1996 and has grown year on year to nearly 800 people worldwide. We provide commissioning, qualification, validation, consulting and project management services to the life sciences and mission critical sectors.

Our people are our greatest asset, and we are committed to delivering excellence while creating opportunities for talented professionals to develop rewarding careers.

As we continue to support major pharmaceutical manufacturing projects across Europe, we are seeking an experienced Lead C&Q Engineer - HVAC to join a high profile project team.

The Lead C&Q Engineer - HVAC will be responsible for leading commissioning and qualification activities for HVAC systems, cleanroom environments and facility infrastructure.

This role will provide technical leadership across design review, commissioning planning, qualification execution and system handover while coordinating closely with engineering, construction, automation, quality and operations teams.

Responsibilities

• Lead commissioning and qualification activities for HVAC, cleanroom and facility systems.
• Review design documentation including P&IDs, specifications, drawings, equipment schedules and design packages.
• Develop and execute CQV deliverables including DQs, risk assessments, traceability matrices, FATs, SATs, commissioning protocols and qualification protocols.
• Coordinate field walkdowns, construction readiness reviews and turnover package assessments.
• Drive punch list resolution and commissioning readiness activities.
• Support startup, energization and operational verification activities.
• Manage vendor interactions and oversee HVAC system testing and balancing activities.
• Ensure all documentation is executed in accordance with GMP requirements and site procedures.
• Provide leadership and mentoring to CQV engineers and project teams.
• Collaborate with cross-functional stakeholders to deliver systems safely, compliantly and on schedule.

Requirements

• Degree in Engineering or related technical discipline.
• 10+ years' commissioning, qualification or validation experience within pharmaceutical, biotechnology or related regulated industries.
• Strong HVAC and cleanroom qualification experience.
• Experience supporting large capital projects from design through handover.
• Working knowledge of ASTM E2500 and risk-based CQV methodologies.
• Experience with electronic validation systems such as Kneat is highly desirable.
• Excellent stakeholder management and communication skills.
• Eligible to work within the EU.