Process Engineer

Position:

Process Engineer Location:

Leiden, Netherlands Contract:

FTE 80-100% On‑site requirement:

2-3 days per week Start:

Immediate Experience target:

5-8 years in pharmaceutical DSP operations process engineering Additional musts:

Engineering background, NPI tech‑transfer experience, Dutch A2, English C1

Role Purpose Maintain, control, and improve drug‑substance production processes. Own designated operational processes. Execute continuous improvement. Enable compliant, reliable, and efficient manufacturing. Act as technical interface across operations, quality, and external partners.

Core Responsibilities Process Ownership Maintain validated manufacturing processes within defined regulatory and operational limits. Monitor output, yield, deviations, and process behavior. Lead data collection, analysis, and reporting for process performance. Process Improvement Drive root‑cause analysis, gap identification, and structured improvement actions. Lead and implement continuous improvement initiatives to reduce downtime, losses, and variability. Conduct Gemba walks and translate observations into sustainable improvements for safety, quality, reliability, cost, and schedule. Change Execution and Technical Assessments Execute complex Product Impact Assessments. Design, initiate, and complete Change Controls. Support risk identification across safety, quality, and compliance. New Product Introduction (NPI) and Tech Transfer Support introduction of new production processes and systems. Collaborate cross‑functionally to ensure readiness, transfer robustness, and operational alignment. Compliance and Documentation Ensure accuracy and completeness of process records. Maintain documentation standards aligned with cGMP and internal policies. Participate in Continuous Process Verification (CPV) by providing data and supplementary analysis. Required Qualifications University degree in Engineering or equivalent technical field. Minimum 3 years relevant experience; preference for 5-8 years specifically in pharmaceutical DSP operations engineering. Demonstrated experience with NPI and tech transfer in a GMP environment. Dutch A2 and English C1. Proficiency in MS Office; capable in data analysis; experienced with business systems. Strong analytical capability, structured thinking, and decision orientation. Ability to operate independently under variable priorities. Stress‑resistant and adaptable. Competencies Technical accuracy and process discipline. Problem‑solving using data, factual analysis, and root‑cause frameworks. Clear communication across operational and leadership levels. Ability to navigate complexity without loss of control or quality.