Associate Manufacturing Fulltime Breda – XDES Projects – Haarlem

XDES Projects

Associate Manufacturing Fulltime Breda

  • Engineering
  • Netherlands, Haarlem
  • Fulltime
  • V-
  • Competitive
  • Accountabilities
    Support the primary production process in process and system (MES/PAS|X).
    Drive continuous improvement of the primary production process (SOP’s, performance reviews, deviations, CAPA’s, electronic Batch Record).

  • Work within full GMP compliance.
  • Assist in training of staff on new or updated processes and procedures.
  • Actively participate in continuous improvement initiatives (e.g., Kaizen/Agility).
  • Own NC’s, CAPA’s, CAPA-EV’s and other investigational records.
  • Develop, revise, and maintain production related (GMP) documentation (SOP’s, FORM’s, pFMEA’s)
  • Drive lifecycle management for MES, GMBR’s, PVL’s and PMBR’s
  • Create proposals and implement initiatives to further develop and train PRD staff on MES.
  • Develop and improve eBR process.
  • Authority

  • Acts as Advise Giver for process and system design principles/improvement initiatives on site level.
  • Acts as Advise Giver for peers, Global MES network, PRD Mgmt and site Mgmt for process and system related issues/solutions.
  • Minimum Requirements

  • Bachelor degree (relevant education) in Automation Processes or Process Design (or the equivalent combination of education and experience).
  • Minimal 3 years’ experience in an industrial environment.
  • Experience in a Good Manufacturing Practices (GMP) environment.
  • Solid understanding of translating Manufacturing process execution in procedures and electronic Batch Record design.
  • Experience in writing procedures and/or records.
  • Proven experience with Lean principles (Kaizen process improvements).
  • Knowledge of problem-solving techniques.
  • Fluent in Dutch and English, both oral and written communication.
  • Experience with transactional data systems (SAP / PAS|X).
  • Knowledge of World Class Manufacturing tools (JIT / 6 Sigma / LEAN / Operational Excellence / SPC / FMEA / RCA).

  • Analytical fact-based thinker
  • Pro-active and result driven implementer
  • Ability to meet deadlines and prioritize work
  • Creative with strong improvement mindset
  • Savvy communicator with high influential skills.
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