Equipment Engineer

Delpharm; Leiden; Remote; EUR 39,000 - 56,000; Full time

Benefits offered by this job

Budget formation et développement

Salaire conforme au marché

Bonus de 10% variable

Pension et avantages

Allocation transport/NS carte

Vélo de société disponible

Ordinateur portable

Job summary

Delpharm recherche un responsable maintenance et QC/QA pour assurer la fiabilité et le bon fonctionnement des équipements analytiques. Vous travaillerez sur site avec l’équipe analytique et les fournisseurs externes pour garantir la conformité GMP et optimiser les processus.

Le candidat idéal possède une formation Life Sciences et >5 années d’expérience GMP, avec expérience en HPLC/GC, gestion du cycle de vie des équipements et maîtrise des documents GMP (déviations, CAPA, validation IQ/OQ).

Qualifications

• 5+ années d’expérience dans un environnement GMP en laboratoire/équipements.
• Maintenance, dépannage et gestion du cycle de vie des équipements.

Responsibilities

• Gérer la performance, la conformité et le cycle de vie des équipements à travers les départements pour optimiser fiabilité et disponibilité.
• Analyser les données de performance, identifier les tendances et mettre en œuvre des améliorations proactives pour réduire les pannes et les arrêts.
• Réaliser la maintenance préventive, les calibrations et coordonner les activités des fournisseurs sans perturber les opérations.
• Traiter les écarts GMP, CAPA, et veiller à la traçabilité et à l’auditabilité des documents.

Skills

Maintenance management

Troubleshooting

Analytical thinking

Stakeholder management

Independent work

Education

MLO/BSc Life Sciences

Tools

CMMS

Validation IQ/OQ

Job description

Description du poste et Missions

About your next job

You’ll be responsible for keeping AD/QC equipment reliable, well-maintained and compliant. Your technical know‑how ensures smooth operation and helps improve processes over time. This is a hands‑on, on‑site role where you’ll work closely with the analytical department and collaborate with both internal teams and external vendors.

We’re a growing organization, creating plenty of opportunities for our people to grow with us. We are looking for someone who is ready to help us build and grow this organisation together. If you enjoy solving technical challenges and are eager for a new adventure, this could be the perfect fit for you!

Your new responsibilities

• Own end-to-end equipment performance, compliance, and lifecycle across departments, ensuring maximum reliability and uptime.
• Analyze performance data, identify trends, and proactively implement improvements to prevent failures and reduce downtime.
• Execute and coordinate preventive maintenance, calibrations, and vendor activities with minimal operational disruption.
• Perform troubleshooting, root cause analysis (RCA), and implement effective CAPAs to prevent recurrence.
• Manage GMP documentation (deviations, change controls, maintenance, calibration, SOPs) ensuring traceability and audit readiness.
• Develop and continuously improve SOPs for equipment operation, maintenance, and compliance.
• Train and support staff in correct equipment use to ensure performance and regulatory compliance.
• Act as SPOC for equipment, coordinating with QA, QC, Production, Facilities, and external vendors.
• Manage vendor services and ensure all external work meets GMP and technical standards.
• Support audits and inspections by providing compliant documentation and demonstrating equipment control.
• Coordinate installation, commissioning, qualification (IQ/OQ), and modification of equipment.
• Support engineering activities including URS, FAT/SAT, and equipment upgrades.
• Utilize CMMS systems to manage maintenance, calibration, and equipment status.
• Prioritize and manage workload across maintenance, quality actions, and operational needs based on risk.
• Stay updated on industry trends and regulations to drive continuous improvement and support investments.

Profil recherché

Your skills and experience

• MLO/BSc in Life Sciences with 5+ years of experience in a GMP-regulated environment with lab equipment (e.g., HPLC, GC).
• Experience in maintenance, troubleshooting, and equipment lifecycle management.
• Knowledge of GMP documentation (deviations, CC, CAPA) and validation (IQ/OQ).
• Familiar with maintenance/calibration systems and preferably CMMS.
• Strong analytical, structured and problem-solving mindset.
• High ownership, able to work independently in a dynamic environment.
• Strong communication and stakeholder management skills.

Informations utiles

Your new benefits

• A great place to work within a team of motivated specialist
• Learning and development opportunities with our training budget
• Market conform salary based on experience (salary range between €3.500 - €5.000)
• 10% Variable pay bonus
• 25 holidays + 6 Delpharm designated days
• Pension scheme including personal options such as partner pension, ANW shortfall and extra savings
• NS business card or Travel allowance by bike or car
• Lease a bike
• Laptop