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).
Responsibilities
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).
Competencies
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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