C

CAI

Operational readiness consulting for pharma

CQV Engineer

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

About the Job

Requirements

  • Experience within the pharmaceutical, biotechnology, medical device, or life sciences industries.
  • Background in commissioning, qualification, validation, engineering, or technical operations.
  • Understanding of good manufacturing practice and regulated manufacturing environments.
  • Experience working with equipment, process systems, clean utilities, facilities, or automation systems.
  • Strong documentation, problem-solving, and stakeholder engagement skills.
  • Ability to work effectively as part of a multidisciplinary project team.

Responsibilities

  • Execute commissioning, qualification, and validation activities in line with project schedules and good manufacturing practice requirements.
  • Support the commissioning, startup, and qualification of equipment, utilities, and process systems.
  • Prepare, review, and execute validation documentation, including protocols, reports, and traceability matrices.
  • Lead or participate in design reviews, factory acceptance tests, site acceptance tests, commissioning, installation qualification, operational qualification, and performance qualification activities.
  • Manage qualification documentation through the full commissioning, qualification, and validation lifecycle.
  • Coordinate activities with engineering, operations, quality, contractors, and equipment vendors.
  • Track progress, identify risks, and support timely project delivery.
  • Assist with change controls, deviations, punch lists, and documentation management.
  • Ensure all activities are performed to safety and compliance standards.
  • Provide technical support during project execution and system handover.

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

Recently Posted Jobs

Explore more opportunities at CAI

See more jobs