• Voltijds
  • BE - Various client locations (average travel time 45 min.)

C&Q Engineer

You will be responsible for coordinating and reviewing CQV deliverables (commissioning, qualification & validation) in line with project specifications in collaboration with the engineering project team.

 

Job Description:

  • You keep an overview of the commissioning and qualification activities and you coordinate them. You look at them with an helicopter view and you ensure structure.
  • You are responsible for the review and approval of commissioning and qualification documents (risk assessments, FAT, SAT, qualification protocols and reports, change control documents).
  • You work with equipment used for pharmaceutical formulation, production and filling.
  • You offer support during system/installation initiation in function of CQV testing activities.
  • You coordinate the implementation of the validation guideline and the SOP for the processes and the equipment (validation life-cycle process, qualifications).
  • You coordinate the review process of CQV deliverables with stakeholders.
  • You escalate quality issues after CQV testing and maintenance of project KPI related to CQV activities.
  • You are the bridge between project engineers and QA stakeholders to handle blocking points.
  • You coordinate change controls for GMP systems.
  • You coordinate the transfer process with the users.
  • You will build strong relationships with both internal and external stakeholders

Profile:

  • You have over 3 years of experience within engineering and within a GMP environment.
  • Activities concerning validation and qualification do not have any secrets for you, as well as handling according to this mindset.
  • You have strong communicational and organisational skills.  
  • Because of previous experiences you have a broad knowledge about technical installations, P&ID and materials.
  • You feel at home within a pharmaceutical production environment and you are a fast learner about technical features of production equipment and processes.
  • For solving problems you use a risk-based approach.
  • You are fluent in speaking and writing in Dutch and English.

Offer:

  • You will become part of a dynamic team in full growth.
  • You will fully develop yourself in our flat company structure with a no-nonsense culture and where there is room for own initiative.
  • Fun colleagues and team activities for free: Saint Nicholas and staff parties, team buildings, …
  • We work together, keep each other sharp and inspire each other: brainstorm sessions, focus groups, …
  • Challenges, trainings, career opportunities and the chance to shape your job.
  • You can count on a competitive and flexible salary package.
  • Extensive offer of fringe benefits including insurances, bonuses, …
  • Financial growth based on your performances
  • Bonuses like profit sharing bonusses and the referral program
  • Work regime tailored to your needs: part-time or full-time

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Inge Neyens 2022
Contact Inge Neyens for more information