Utilities Calibration Coordinator

Cagents; Netherlands; On-site; EUR 55,000 - 75,000; Full time

Job summary

Cagents is seeking an experienced Utilities Calibration Coordinator to manage the calibration programme for GMP-critical utilities and process equipment in the Netherlands. The role requires strong exposure to calibration systems and compliance with regulatory requirements. The successful candidate will collaborate with Engineering, CQV, and QA teams to ensure instrumentation integrity and valid status.

Applicants should have a degree in Engineering or related fields, and prior experience in a regulated GMP environment is essential. Flexibility in work hours and the ability to work on-site are required.

Qualifications

• Degree or equivalent experience in Engineering, Instrumentation or Utilities in the Life Sciences.
• Proven experience in a pharmaceutical or regulated GMP environment.
• Strong exposure to utilities calibration.

Responsibilities

• Coordinate and manage calibration activities for critical utilities systems.
• Ensure all process and utility instrumentation is calibrated in line with GMP requirements.
• Support and/or lead instrument and equipment criticality assessments.

Skills

Utilities calibration

Instrument criticality assessment

Documentation compliance

Education

Degree in Engineering, Instrumentation or Utilities

Tools

CMMS systems (e.g. Maximo, SAP PM, Blue Mountain)

Job description

Job Title: Utilities Calibration Coordinator

Location: Netherlands

Contract Type: Staff or Contract (12-month project)

Job Summary

We are seeking an experienced Calibration Coordinator with strong exposure to pharmaceutical utilities systems, instrument criticality assessment, and validation support. This role will be responsible for managing the calibration programme for GMP‑critical utilities and process equipment, ensuring compliance with regulatory requirements and supporting commissioning, qualification, and validation activities. The successful candidate will work closely with Engineering, Utilities, CQV, QA, and external calibration vendors to ensure all instrumentation is maintained in a validated and compliant state.

Key Responsibilities

• Coordinate and manage calibration activities for critical utilities systems.
• Ensure all process and utility instrumentation (pressure, temperature, flow, level, conductivity, TOC, etc.) is calibrated in line with GMP requirements.
• Schedule, track, and close calibration work orders using a CMMS/EAM system (e.g. Maximo, SAP PM, Blue Mountain).
• Support and/or lead instrument and equipment criticality assessments in line with GMP 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 CAPAs.

Qualifications

• Degree or equivalent experience in Engineering, Instrumentation or Utilities in the Life Sciences.
• Proven experience in a pharmaceutical or regulated GMP environment.
• Strong exposure to utilities calibration.
• Experience with instrument criticality assessment.
• Hands‑on experience working alongside CQV/validation teams.
• Strong documentation and compliance mindset.
• Experience using CMMS systems.

Other Requirements

• Must be able to commit to a minimum 40‑hour work week, with flexibility based on project needs.
• This is a site‑based role.
• Eligible to work in the EU without the need for visa sponsorship, now or in the future.