Utilities Calibration Coordinator

CAI; Netherlands; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A professional services company in the Netherlands seeks an experienced Utilities Calibration Coordinator to manage the calibration program for GMP-critical utilities and equipment. The ideal candidate will have a degree in Engineering or equivalent and proven experience in a pharmaceutical GMP environment. Strong exposure to utilities calibration and hands-on experience with CQV teams are essential. This role is site-based, requiring a commitment to a minimum of 40 hours per week and flexibility as project needs dictate.

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.

Responsabilités

• Coordinate and manage calibration activities for critical utilities systems.
• Ensure all process and utility instrumentation is calibrated in line with GMP requirements.
• Support internal audits and regulatory inspections.

Connaissances

Pharmaceutical Utilities Systems

Instrument Criticality Assessment

Validation Support

GMP Compliance

Documentation Compliance

Formation

Degree in Engineering, Instrumentation or Utilities

Outils

CMMS Systems (e.g. Maximo, SAP PM)

Description du poste

CAI Overview

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high‑stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field‑tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach.

We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement.

We’re not interested in how it used to be done. We’re obsessed with how it will be done.

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.