C

CAI

Operational readiness consulting for pharma

Senior CQV Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time¥8M - ¥10M /yr

About the Job

Requirements

  • A relevant science or engineering bachelor's or master's degree, or equivalent years of hands-on experience.
  • Five to twelve years of experience performing commissioning and/or qualification activities in an FDA-regulated industry.
  • Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus.
  • Knowledge of technical issues that may arise in CQV projects.
  • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
  • High attention to detail.
  • Ability to multitask and take initiative to accomplish assigned tasks accurately by established deadlines.
  • Ability to work independently while quickly building and nurturing a project team.
  • Experience planning and directing commissioning and qualification activities.
  • Proficiency in life science manufacturing processes such as biotechnology, aseptic processing, aseptic fill/finish, oral solid dosage, or gene therapy, or equivalent experience.
  • Proficiency in Microsoft Word and Excel.
  • Business-level proficiency in both English and Japanese.
  • Ability to travel if required.

Responsibilities

  • Create commissioning, qualification, and validation documentation for pharmaceutical or medical-device production facilities, utilities, and equipment.
  • Create CQV protocols, perform work at customer sites, and prepare summary reports.
  • Plan and coordinate documentation and execution work, manage execution cycles, and provide direction to small teams.

Desired Qualifications

  • Experience with facilities and equipment startup, walkdowns and troubleshooting, utilities such as WFI, RO, and HVAC, building automation, pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design reviews, P&IDs, and generation and execution of IQ/OQ/PQ protocols.

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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