C

CAI

Operational readiness consulting for pharma

Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time$75k - $90k /yr

About the Job

Requirements

  • A bachelor's degree in a science or engineering field, or equivalent experience.
  • Two to four years of experience in commissioning and qualification in a regulated industry.

Responsibilities

  • Develop documentation for commissioning, qualification, and validation activities.
  • Write and execute field-verification protocols.
  • Develop summary reports at client sites.
  • Focus on pharmaceutical facilities, utilities, and equipment.
  • Plan and coordinate work.
  • Direct small teams in document development and/or execution.

Desired Qualifications

  • Familiarity with ISPE Baseline Guide 5 (Second Edition).
  • Experience with facilities and equipment startup.
  • Experience with walk-downs and troubleshooting.
  • Experience with utilities, including WFI, RO, and HVAC.
  • Experience with upstream and downstream processing.
  • Experience with purification and recovery.
  • Experience with building automation.
  • Experience with pharmaceutical manufacturing processes.

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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