C

CAI

Operational readiness consulting for pharma

Senior Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time$87.2k - $94.6k /yr

About the Job

Requirements

  • A bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences is required, although relevant experience may substitute for education.
  • At least 3 years of related experience in the Pharmaceutical/Life Sciences industry.
  • Essential experience in a Good Manufacturing Practice (GMP) environment.
  • Outstanding oral and written communication skills.
  • Strong problem-solving abilities.
  • Customer-focused mindset.
  • Willingness and flexibility to travel throughout the United States and potentially internationally.

Responsibilities

  • Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety.
  • Deliver commissioning and qualification activities in alignment with project schedules.
  • Track and report progress of CQV efforts.
  • Support the generation and review of commissioning and qualification procedures for client projects.
  • Review and revise qualification-related documents, including standard operating procedures, master plans, and execution plans.
  • Assist with CQV review and qualification of equipment design.
  • Support planning of commissioning spares and consumables.
  • Allocate project resources for efficient execution.
  • Coordinate support and logistics during CQV execution.
  • Support execution of design reviews, equipment shakedown, commissioning, factory acceptance tests (FATs), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
  • Coordinate with project contractors and equipment vendors to execute required testing.

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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