Manufacturing Process Engineer F/M/X

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique TN Belgium Temps plein

Social network you want to login/join with:

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 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.
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)
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