C

CAI

Operational readiness consulting for pharma

Senior COHE / LOTO Engineer

Environmental Health & SafetyConfirmed live in the last 24 hours
Full-timeLimerick, IrelandNo salary listed

About the Job

Requirements

  • A degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline is required.
  • At least 10 years of experience in Commissioning & Qualification, CQV, or Validation is required.
  • Strong working knowledge of Good Manufacturing Practice (GMP) requirements and FDA and EMA regulations is required.
  • Strong hands-on upstream and downstream bioprocess knowledge is required.
  • Extensive experience with bioreactors, filtration, and concentration systems is required.
  • Excellent documentation, communication, and stakeholder engagement skills are required.
  • Applicants must be eligible to work full-time in Ireland.
  • Applicants must be willing to travel within Ireland and internationally, if required.
  • Applicants must commit to a minimum 40-hour work week, with flexibility based on project needs.

Responsibilities

  • Develop comprehensive Control of Hazardous Energy (COHE) plans for all in-scope equipment before and during commissioning activities.
  • Identify, assess, and document hazardous energy sources, including electrical, mechanical, hydraulic, pneumatic, chemical, and thermal systems.
  • Conduct field verification of Lockout/Tagout (LOTO) procedures to ensure accuracy, compliance, and applicability to the site.
  • Maintain and manage LOTO devices, tags, hasps, and lockout kits across the facility.
  • Support commissioning and start-up teams to ensure adherence to hazardous energy control procedures.
  • Coordinate COHE/LOTO requirements with the main contractor, Emerson Automation, vendor teams, and Utilities.
  • Serve as the site subject matter expert for hazardous energy control, providing technical guidance and oversight to personnel.
  • Maintain current COHE documentation aligned with site Environmental, Health, and Safety (EHS) requirements and the Permit to Work system.
  • Support risk assessments and update COHE documentation as system configurations evolve during commissioning.
  • Ensure activities comply with applicable safety legislation and site-specific procedures.

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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