This biotech client develops projects starting from project definition and scope up to and including start-up in production, after which the new installations are handed over to production & maintenance. They are in need of a CQ Engineer (Utilities) to join their team ASAP!
Being part of the Engineering team means being central within the organisation and having a high exposure; from the work floor to the site leadership team!
Start Date: ASAP - end of year. Must be freelancer.
You are a member of the engineering team for clean and black utilities that is working on the Z900 project. The project is part of the expansion strategy of the company for an increase of product capacity and is now at the start of the construction phase. As CQ engineer you will be responsible for:
- Writing SAT documents in order to perform the commission of skids, systems and/or packages
- Writing IQ/OQ/PQ documents and perform the qualification
- Carry out validation tests and commissioning.
- You ensure a complete as-built file and handover of the project to the internal customers production and maintenance.
- University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
- Expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA
- Understanding of good practices in biopharmaceuticals, current Industry standards, regulatory requirements and Authority expectations regarding CQV.
- Experience in Pharmaceutical production environment, commissioning & qualification.
- You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
- Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
- Use a risk-based approach for problem solving and prioritization of tasks.
- Good GMP background and quality system management
- Blow a quality and compliance mindset through the qualification activities
- You have a field experience with:
- CQV activities for upstream equipment
- Change management
- Project document management
You must be located in Belgium and able to work both on/off site.
Send your CV to firstname.lastname@example.org to discuss further!