C

CAI

Operational readiness consulting for pharma

Utilities Calibration Coordinator

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNetherlandsNo salary listedIn-person

About the Job

Requirements

  • A degree or equivalent experience in Engineering, Instrumentation, or Utilities in the Life Sciences.
  • Proven experience in a pharmaceutical or regulated Good Manufacturing Practice environment.
  • Strong exposure to utilities calibration.
  • Experience with instrument criticality assessment.
  • Hands-on experience working alongside commissioning, qualification, and validation teams.
  • Experience using computerized maintenance management systems.

Responsibilities

  • Coordinate and manage calibration activities for critical utilities systems.
  • Ensure process and utility instrumentation, including pressure, temperature, flow, level, conductivity, and total organic carbon instruments, is calibrated in line with Good Manufacturing Practice requirements.
  • Schedule, track, and close calibration work orders using a computerized maintenance management system or enterprise asset management system, such as Maximo, SAP PM, or Blue Mountain.
  • Support and/or lead instrument and equipment criticality assessments in line with Good Manufacturing Practice and risk-based approaches.
  • Classify instruments as direct impact, indirect impact, or no impact to product quality and patient safety.
  • Ensure calibration strategies align with criticality, risk, and validation status.
  • Maintain criticality documentation and ensure alignment with site procedures.
  • Ensure calibration status supports validated state maintenance.
  • Participate in change control, deviations, and impact assessments related to calibrated systems.
  • Review and approve calibration certificates and reports.
  • Support internal audits, regulatory inspections, and site readiness activities.
  • Investigate calibration failures and out-of-tolerance results, supporting root cause analysis and corrective and preventive actions.
  • Commit to a minimum 40-hour work week, with flexibility based on project needs.
  • Work in a site-based role.

Desired Qualifications

  • Strong documentation and compliance mindset.

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

Recently Posted Jobs

Explore more opportunities at CAI

See more jobs