Job description
Scope of Work
As a Manufacturing Engineer, you will lead and support projects and initiatives. Your role will include:
* Project Management: Independently develop and implement initiatives and process improvements.
* Technical Support: Provide guidance during production issues, ensuring adherence to cGMP guidelines and production standards.
* Root Cause Analysis: Assist in investigations of process deviations, performing impact assessments and recommending corrective/preventive actions.
* Continuous Improvement: Support daily performance enhancement through expert advice and technical knowledge.
* Collaboration: Work alongside manufacturing, Quality Assurance, and Technical Services to resolve ad hoc issues.
* Data Coordination: Support process data trending to ensure process robustness.
* Subject Matter Expert (SME): Act as a point of contact for internal and external audits.
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Profile Requirements
Experience:
* Solid technical knowledge of biopharmaceutical production and process equipment (both upstream and downstream).
* Familiarity with GMP regulations and Quality/Compliance standards.
* Enthusiastic, eager to learn, and able to embrace challenges.
* Resilient under pressure and accustomed to meeting deadlines.
* Strong team player with the ability to work independently.
* Excellent communication skills in a cross-departmental environment.
Education:
* Master’s degree or equivalent experience.
* Experience in change and project management is an advantage.
* Familiarity with BioLIMS, Datastream, Delta V, and MES is a plus.
* Knowledge of biologics manufacturing (e.g., mAbs fed-batch production) is preferred.
* Availability for partial on-site work.
* Languages Required: English (Fluent) and Dutch (Fluent)
What We Offer: