DSP Process Engineer Leiden, Netherlands – Full-time
Company Description
A leading global biotechnology organization dedicated to advancing human health through innovation in biopharmaceutical development and manufacturing. The site in Leiden is recognized for its technical excellence, operational efficiency, and commitment to developing cutting-edge therapies that make a lasting impact on patients worldwide.
Job Description
As a Process Engineer, you will play a pivotal role in maintaining and optimizing production processes, ensuring operational excellence, and driving continuous improvement across manufacturing operations. You will act as a bridge between operations, management, and technical teams, ensuring processes meet the highest standards of quality, safety, and performance. Your expertise will also support new product introductions, technology transfers, and the implementation of process improvements across the site.
Key Responsibilities:
Support the implementation of production and process objectives, including the introduction of new processes and optimization of existing ones.
Ensure processes operate within validated and regulatory limits, achieving expected yields and maintaining compliance with GMP.
Collaborate cross-functionally to identify and execute improvements that enhance reliability, safety, and efficiency.
Manage data collection, analysis, and reporting to support continuous process improvement and operational decision-making.
Lead process improvements while maintaining compliance with safety, quality, and regulatory expectations.
Conduct formal issue resolution and risk assessments related to safety, product quality, and regulatory compliance.
Lead Product Impact Assessments and Change Control processes from initiation to completion.
Perform Gemba walks to identify and implement sustainable improvements in safety, quality, reliability, cost, and scheduling.
Support Continuous Process Verification (CPV) activities by providing data and performing additional research as needed.
Essential Requirements:
Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or a related field (Engineering background required).
5–8 years’ experience in the pharmaceutical or biopharmaceutical industry.
Strong background in Downstream (DSP) Operations Process Engineering.
Demonstrated experience in New Product Introduction (NPI) and Technology Transfer.
Proven knowledge of GMP, process optimization, deviation handling, and regulatory expectations.
Proficiency in MS Office, data analysis, and relevant business systems.
Language proficiency: English (C1) required/ Dutch is an advantage
Excellent analytical, problem-solving, and organizational skills.
Proactive, adaptable, and resilient under pressure, with strong interpersonal and communication abilities.
Capable of working independently and collaboratively in a fast-paced environment.
Additional Insights:
Location: Leiden, Netherlands (3–4 days on-site)
Contract Type: 1-year fixed-term contract (no freelancers)