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.