(Senior) Commissioning, Qualification, Validation (CQV) engineer, location Switzerland (multiple positions, various projects)
Our client is a consultancy organization operating in the (Bio-) Pharmaceutical, High-end food, and Oil, Gas, and Chemical industries. They have their head office in the Netherlands and a second location in Switzerland. On behalf of this client, we are looking for a:
As part of a project team, you are responsible for the commissioning, qualification, and validating of process equipment and critical building and utility systems within their client GMP manufacturing facilities. Your work includes designing, implementing, and documenting these qualifications and their lifecycle management in compliance with all applicable regulatory and internal quality standards (FDA and EU regulations).
You will be part of a fast-growing international organization with more than 150 professional European colleagues. You work in a dedicated, experienced team in an informal atmosphere. Their back office will support you in all aspects to let you focus on your role and projects.
Your primary responsibilities:
- Responsible for all aspects of CQV activities as required by schedule and project timelines.
- Provide the necessary support in a timely, efficient, and quality manner.
- Designing, developing, executing, writing, and archiving Commissioning and Quality 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.
- Analyze and interpret validation data and results and summarize findings in final reports.
- Analyze 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 strategy and approach and conducting and coordinating validation testing.
- Keep good contact with team members, share knowledge, and troubleshoot.
- Bachelor’s degree in engineering, science, or related technical field, chemical or mechanical engineering, or a similar based on education and experience.
- At least five years of experience within a GMP environment and three years of CQV, preferably within the biotechnology industry.
- In-depth knowledge of cGMP regulations.
- Excellent understanding of controlled documentation and data systems.
- Able to travel and work at client locations in Switzerland.
- Excellent language skills at a professional level in English and German.
What they offer:
- A challenging position within a dynamic and rapidly growing organization.
- Inspiring projects within our life sciences network.
- A good salary, depending on education, knowledge, and experience.
- An attractive bonus scheme and great benefits, and a personal training budget so that you can continue to develop yourself.
- Being part of our motivated, dedicated, and cooperative team.
Position available for candidates that are seeking employment and independent contractors.
If you are interested in this position, please apply using the apply option, and we will contact you as soon as we can.