C

CAI

Operational readiness consulting for pharma

CQV Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time€85k - €95k /yr

About the Job

Requirements

  • Previous CQV experience within pharmaceutical, biotech, or life sciences manufacturing environments.
  • Strong understanding of commissioning and qualification methodologies.
  • Experience supporting regulated manufacturing facilities and associated utility systems.
  • Familiarity with GMP documentation, protocol execution, and project lifecycle delivery.
  • Must be eligible to work in the EU without visa sponsorship, now or in the future.
  • The role is site-based.

Responsibilities

  • Execute commissioning and qualification activities for process, utility, and facility systems.
  • Develop, review, and execute qualification documentation in line with project and regulatory requirements.
  • Support system turnover, startup, and operational readiness activities.
  • Liaise with engineering, quality, operations, and project stakeholders to ensure successful project delivery.
  • Participate in walkdowns, punch-list resolution, and troubleshooting activities.
  • Ensure compliance with site quality, safety, and GMP procedures.

Desired Qualifications

  • Exposure to complex process equipment and containment-focused manufacturing operations.
  • Experience in high-containment or high-potency manufacturing environments.
  • Experience in process equipment qualification.
  • Experience with manufacturing support systems and clean utilities.
  • Experience in HVAC and facility qualification.
  • Experience in packaging, processing, or solid dosage manufacturing operations.
  • Experience in safety-critical or hazardous processing environments.

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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