CAI

Operational readiness consulting for pharma

Lead Commissioning and Qualification Engineer - HVAC

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeGermanyNo salary listedIn-person

About the Job

Requirements

A degree in Engineering or a related technical discipline is required.
At least 10 years of commissioning, qualification, or validation experience within pharmaceutical, biotechnology, or related regulated industries is required.
Strong HVAC and cleanroom qualification experience is required.
Experience supporting large capital projects from design through handover is required.
Working knowledge of ASTM E2500 and risk-based commissioning, qualification, and validation methodologies is required.
Applicants must be eligible to work within the European Union.

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 commissioning, qualification, and validation deliverables, including design qualifications, risk assessments, traceability matrices, factory acceptance tests, site acceptance tests, 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 good manufacturing practice requirements and site procedures.
Provide leadership and mentoring to commissioning, qualification, and validation engineers and project teams.
Collaborate with cross-functional stakeholders to deliver systems safely, compliantly, and on schedule.

Desired Qualifications

Experience with electronic validation systems such as Kneat is highly desirable.
Excellent stakeholder management and communication skills.

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.

About the Company

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size: 1,001-5,000
Company stage: Pre-seed
Total funding: $3.4M
Headquarters: Indianapolis, IN
Founded: 1996

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