Jobs

Change Control / cGMP Engineer

Discipline
Engineering
Sector
Life Science
Location
Belgium
Vacancy ID
52354

Responsibilities

  • As a Change Control / cGMP Engineer you are responsible for the technical support of the production process, root cause analyses, larger projects etc. and ensure the coordination and implementation of continuous improvements within the production department, taking into account all facets within the cGMP guidelines.
  • You provide continuous process support and provide both ad hoc and proactive advice, service and technical expertise. 
  • You monitore processes, adjust and/or escalate where necessary. 
  • You initiate and execute specific investigations into existing and innovative processes and technologies, as well as developing and implementing new (sub)processes and technologies. 
  • You write, revise, provide input, give training of operational procedures, assiste in the implementation of new procedures, and ensure correct compliance with SHE guidelines house rules, GMP guidelines, legal standards, regulations and regulations within own department. 
  • You ensure periodic and ad hoc communication about the state of affairs and the preparation of relevant reports. 
  • You proactively follow trends and developments within your own field, as well as build up and share knowledge within this domain. 
  • You initiate consultations with internal and inter-organizational experts across disciplines. 
  • You maintain, adjust and communicate documentation and process knowledge. 

Requirements

  • Experience in Change Control in GMP environment and/or Deviation handling in a product environment (GMP) (process engineer, change control engineer, cGMP engineer, QA engineer). 
  • Pharma and Biotech experience is a must. 
  • Knowledge of Delta V or SAP is an advantage. 
  • Good communication skills in Dutch and English (writing). 
  • Analytical, stress resistand and strucutred. 
  • Quickly deployable. 
  • Mature. 

Let us handle the details

We at STAR are happy to take care of the details

01 // Education and development

Standing still in this fast-changing market is not an option. That's why you can combine this position at STAR with courses to further your specialist knowledge and skills. It's the best of all worlds: work, learn and be part of a challenging project all at the same time. Whether you need a springboard to launch your career or simply want to update your expertise, the training programmes offered by our STAR Academy ensure that your qualifications are always in line with your ambitions.

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