C

CAI

Operational readiness consulting for pharma

Quality Assurance Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLimerick, IrelandNo salary listedIn-person

About the Job

Requirements

  • A degree in Engineering, Science, Biotechnology, or a related discipline is required.
  • At least 3 years of validation experience within pharmaceutical, biotechnology, medical device, or life sciences environments is required.
  • Experience qualifying laboratory and/or manufacturing equipment in GMP-regulated facilities is required.
  • Strong understanding of Good Manufacturing Practice and validation principles is required.
  • Experience authoring and executing validation documentation is required.
  • Knowledge of deviation management, change control, and Corrective and Preventive Action processes is required.
  • Eligibility to work in Ireland is required.

Responsibilities

  • Execute Installation Qualification, Operational Qualification, and Performance Qualification activities for Good Manufacturing Practice equipment and systems.
  • Prepare and review validation protocols, reports, and lifecycle documentation.
  • Support commissioning, qualification, and validation projects from planning through execution.
  • Perform risk assessments and support deviation, Corrective and Preventive Action, and change control activities.
  • Ensure compliance with Good Manufacturing Practice, Good Distribution Practice, and regulatory requirements.
  • Collaborate with Quality, Engineering, Manufacturing, and Laboratory teams.
  • Participate in audits and inspection readiness activities.
  • Support equipment lifecycle management and continuous improvement initiatives.

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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