My client is a renowned Biotech in Belgium who are currently searching for several Engineers (CQV; Process; Utilities) to support on-going projects and expansion to existing plants. They are a fast-paced, innovative company, and look for dynamic people who can enjoy the ride with them! Right now, they urgently need a CQ Engineer to support the teams in achieving their project goals.
Hands-on attitude, motivated, quality mindset and responsible in, coordinating, and reviewing CQV deliverables in line with project specifications in cooperation with project team
- To ensure oversight of the commissioning (FAT, SAT) & qualification (IQ, OQ, PQ) activities.
- Responsible for reviewing and approving commissioning and qualification documents (Risk Assessment, SAT, qualification protocols and reports, …).
- Coordinate and facilitate punchlist items / incidents resolution
- Ensure CQV protocols are executed according to Good Documentation Practices.
- Support during system/installation start-up in function of CQV test activities
- Coordinate the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
- Coordinate the implementation of adequate qualification strategy in compliance with FDA, EMEA and International quality standards.
- Provide support for inspection readiness – regarding system Validation
- Coordinate the review process of CQV deliverables with stakeholders
- Escalate quality issues after CQV testing and maintain project KPI related to CQV activities
- Play the link between PE department and QA stakeholder to address blocking points
- Coordinate change controls for GMP and GEP systems
- Support risk analysis activity as required per the project
- Accountable for writing Validation report
- Coordinate the handover process with the users
- Build a strong partnership with key stakeholders; both internal & external
- 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 speak and write fluent English, Dutch and/or French
- Start date: November 2021.
- Contract duration: Till end of Q2 2022 with option for extension.
- Project/Mission duration: Till end of Q2 2022.
- Type of project(s): Utilities & Production capacity extension & improvement projects.