Manufacturing Process Engineer F/M/X
il y a 2 semaines
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Manufacturing Process Engineer [F/M/X]Client:Amaris Consulting
Location:Not specified
Job Category:Other
EU work permit required:Yes
Job Reference:8211d112175c
Job Views:2
Posted:06.03.2025
Expiry Date:20.04.2025
Job Description:Scope of WorkAs 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.
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)
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