- Voltijds
- Mechelen
C&Q Engineer
This vacancy is for a specific location, but we have C&Q positions available throughout Belgium. Interested? Apply now!
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