CQV Engineer / Lead
Adryan is an internationally operating services group. From our offices in The Netherlands and Switzerland, we offer a full range of services for the (bio) pharmaceutical and high-end food industries. We are specialised in the areas of project management, engineering, CQV and compliance.
As a hands-on CQV engineer / lead , you are part of a project team and are responsible for the commissioning, qualification and validation activities of GMP facilities, process equipment and critical building and utility systems within our client’s life sciences production facility. This includes the design, implementation and documentation of these qualifications and their lifecycle management, in compliance with all applicable regulatory and internal quality standards (FDA and/or EU regulations).
Key responsibilities:
- Within a smoothly running project team, you’ll be accountable for all aspects of CQV activities as required by schedule and project timelines.
- Providing the required support in a timely, efficient and quality manner.
- Designing, developing, executing, writing and archiving C&Q documentation, such as systems commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) (IOPQ) and validation protocols and reports, according to quality standards and guidelines for the life sciences industry.
- Analysing and interpreting validation data and results, and summarising findings in final reports.
- Analysing the design to identify the GMP requirements for validation.
- Resolving protocol and execution discrepancies, finding a satisfactory conclusion and planning follow-up actions as required
- Making recommendations and decisions (when appropriate) regarding test strategies and approaches
- Conducting and coordinating validation testing
- Maintaining good contact with team members, sharing knowledge, and troubleshooting.
Job requirements
- Bachelor’s degree in engineering, science or related technical field, e.g. HTS in chemical or mechanical engineering, or an equivalent combination of education and experience
- Proficient with computers (MS Office). Solid understanding of controlled documentation and data systems.
- In-depth knowledge of cGMP regulations.
- In-depth knowledge of process validation.
- 5+ years of experience within a GMP environment, preferably within the biotech industry
- 3+ years of experience with CQV
- Flexible, a team player, a problem solving mindset and positive attitude
- Customer and result-oriented
- Forward-looking attitude and engaging cooperative style
- Good communication and interpersonal skills
Job offer
- A challenging position within a dynamic and rapidly growing organisation.
- Inspiring projects within our life sciences network
- A good salary, depending on education, knowledge and experience.
- An attractive bonus scheme and excellent fringe benefits
- Being part of our motivated, dedicated and cooperative Adryan team, with a helpful back office that allows you to focus on your role and project.
