Equipment Engineer

Delpharm Leiden

CDD / Temporaire Leiden Pharmaceutique / Biotechnologique
Publiée le
14/04/2026
Contrat
CDD / Temporaire
Localisation
Leiden
Taille équipe
Rémunération
Inconnue
Télétravail non autorisé
Missions clés Assurer la fiabilité et la conformité des équipements AD/QC. · Analyser les données de performance et mettre en œuvre des améliorations. · Gérer la documentation GMP et assurer la préparation aux audits. · Former le personnel à l'utilisation correcte des équipements. · Coordonner les activités de maintenance préventive et de calibration.
Profil recherché Résolution de problèmes · Management · Communication · Analyse
Outils & compétences HPLC, GC, GMP, CMMS, CAPA, SOPs, RCA, Quality by Design (QbD), data science, lean principles

Le poste en détail

source:job.delpharm.com 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 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. publication_date:2026-04-10T13:56:36.000Z contract_type:CDD