Process Engineer Groningen • SIRE Life Sciences

The company
The organization is a globally recognized pharmaceutical manufacturer specializing in the production of complex biologic medicines. Based in the Netherlands, the facility supports both clinical and commercial manufacturing within a regulated GMP environment. Operations include production, quality control, and technical support for biologics used in the treatment of serious health conditions.
As part of a broader international healthcare group, the company emphasizes innovation, compliance, and continuous improvement, contributing to the reliable supply of high-quality therapeutic products to markets worldwide.

Role Description
Daily supports manufacturing operation on the manufacturing floor by troubleshooting and addressing deviations. Plans and conducts activities related to supporting the base business, i.e., day to day yield analyses, follow up and working across teams to reduce deviations. Continuously evaluating process cost, quality, capability alternatives, and problem solving and decision-making tools. Proactively keeps up to date on current and emerging technologies. Works with a safety, quality, and service mindset.

Responsibilities
Daily Operations & Troubleshooting:
-Supports manufacturing operations by troubleshooting deviations on the production floor.
-Conducts yield analyses and collaborates across teams to reduce deviations.
-Evaluates process cost, quality, and capability using problem-solving tools.
-Stays updated on emerging technologies to drive continuous improvement.

Safety, Quality & Compliance:
-Acts as an ambassador for safety, quality, and service.
-Addresses/escalates product/process complaints and drafts/adapts SOPs.-
-Investigates technical bottlenecks and provides detailed reports.

Process Optimization & Engineering Support:
-Participates in engineering activities to develop high-quality processes.
-Conducts design reviews to improve manufacturability.
-Implements equipment/process upgrades (vendor evaluation, capability studies).
-Leads experiments, develops process specs, and procures tools.
-Edits/publishes process documentation and training materials.

Qualifications
-Minimum vocational-level education (preferably a technical degree).

Experience:
-2–4 years in manufacturing (preferably in highly regulated industries).

Technical Knowledge:
-Manufacturing principles & process validations.
-Preferred: GMP, QSR, ISO 13485/14971, EU MDR, LEAN Six Sigma (Green Belt).

Competencies:
-Strong communicator (fluent in Dutch & English).
-Flexible, detail-oriented, and results-driven.
-Works well independently and in teams.
-Comfortable in cleanroom and highly regulated environments.

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