CQ Engineer (CQV) x 2 Ref:1616
SPGL is a dynamic and well established professional technical services group, operating in a range of market sectors including Bio-Pharmaceuticals, Medical Devices & Diagnostics, Healthcare, Regulated Consumer Products, Chemicals & Mission Critical. We are a responsible, diverse and inclusive organisation, driven by our vision of ‘making quality a way of life’ and a strong desire to achieve more for our customers. We are proud to have a great team of highly skilled, smart professionals who help, care and support both our clients and each other.
- 1x CQV Engineer – Production / Process equipment inside the clean room
- 1x CQV Engineer – Clean (& Black) Utilities
- Working in a department of 25 engineers
- GMP background
- Quality & Compliance mindset
- 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
- Strong communication, organizational and influencing skills to work transversely.
- Good team player, who can also work independently.
- You speak and write fluent English, Dutch and/or French
- 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 punch list 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
What SPGL can offer you
We are a people centric company where our staff are the heart and soul of our organisation. If you’re looking for a forward-thinking workplace and see yourself as a dynamic professional, come and join our team and you can expect:
- Competitive starting salary
- Excellent private healthcare
- Pension and life insurance
- A variety of challenging projects, with blue-chip customers
- International project assignments
- Continuous training and personal development
- Strong career pathway
- A mix of young and experienced professionals
- Multi-cultural and caring organisation
- An equal opportunity employer
- Regular team building events and social gatherings
For further information on this role please e-mail email@example.comApply