C

CAI

Operational readiness consulting for pharma

Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeAustraliaNo salary listed

About the Job

Requirements

  • A BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.
  • At least 4 years of relevant commissioning or validation experience in an FDA-regulated industry.
  • Experience with autoclave or parts washer qualification is required.
  • Expertise in Microsoft Word and Excel is required.
  • Excellent oral and written English are required.
  • The ability to work in Australia without sponsorship is required.
  • The ability to travel domestically and internationally if required.

Responsibilities

  • Develop documentation for commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
  • Write and execute protocols, including field verification, and develop summary reports at client sites.
  • Support onsite and offsite activities, including factory acceptance tests, site acceptance tests, installation/operational qualification and performance qualification executions, and system walkdowns.

Desired Qualifications

  • Experience with one or more of the following is desired: facilities and equipment startup; walkdowns and troubleshooting; utilities such as water for injection, reverse osmosis, or heating, ventilation, and air conditioning; building automation; other pharmaceutical manufacturing processes and equipment; factory or site acceptance testing; user requirements specifications; design review; piping and instrumentation diagrams; installation, operational, or performance qualifications; and their generation and execution.
  • Technical problem-solving and troubleshooting skills.
  • High attention to detail.
  • Ability to multitask and take initiative to complete assigned tasks accurately by established deadlines.
  • Ability to work independently.

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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