Associate Manufacturing Fulltime Breda

• Engineering
• Netherlands, Haarlem
• Fulltime
• V-51351
• 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.