Equipment Engineer

Leiden Bio Science Park; Leiden; On-site; EUR 39,060 - 55,800; Full time

Benefits offered by this job

Learning and development opportunities

Pension scheme including personal options

Market conform salary

25 holidays + 6 Delpharm designated days

NS business card or Travel allowance

Lease bike plan

Laptop

Job summary

Leiden Bio Science Park in Leiden is looking for a specialist to manage equipment performance and compliance in a GMP-regulated environment. Responsibilities include analyzing performance data, conducting preventive maintenance, and developing SOPs to ensure maximum reliability.

The ideal candidate has over 5 years of experience with lab/production equipment and strong analytical skills. Benefits include a competitive salary ranging from €3,500 to €5,000, along with a variable pay bonus and extensive holidays.

Qualifications

• 5+ years' experience in a GMP-regulated environment with lab/production equipment.
• Knowledge of GMP documentation and validation.
• Strong analytical and structured problem-solving mindset.

Responsibilities

• Own end-to-end equipment performance, compliance, and lifecycle.
• Analyze performance data and implement improvements.
• Execute and coordinate preventive maintenance and calibrations.
• Manage GMP documentation ensuring traceability.
• Develop and improve SOPs for equipment operation.

Skills

GMP-regulated environment experience

Analytical skills

Problem-solving mindset

Strong communication skills

Stakeholder management

Tools

HPLC

GC

CMMS systems

Job description

It’s a great fit for someone who enjoys solving technical challenges and wants to make things run better every day!

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.

Qualifications

• 5+ years' experience in a GMP-regulated environment with lab/production equipment (e.g., HPLC, GC).
• Knowledge of GMP documentation (deviations, CC, CAPA) and validation (IQ/OQ).
• Strong analytical, structured and problem‑solving mindset.
• Strong communication and stakeholder management skills.

Benefits

• A great place to work within a team of motivated specialists.
• Learning and development opportunities with our training budget.
• Market conform salary based on experience (salary range between €3,500 - €5,000).
• 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 bike plan.
• Laptop.