The Company
The company is a global biotechnology company dedicated to improving the lives of patients. In Breda they focus on preparing, planning, and coordinating the shipping and distribution of clinical trial materials.
Role Description
We are seeking a CQV Engineer to join the site Engineering team under GMP standards. Reporting to the Senior Manager of Validation & Compliance, this role involves supporting technical projects with minimal supervision. The CQV Engineer will be responsible for developing and executing commissioning, qualification, and validation strategies, ensuring compliance with internal requirements and standard procedures. This is a hands-on position focused on packaging systems and validation documentation.
Responsibilities
- Preparing and updating validation documents such as System-level criticality assessments, commissioning, qualification, and validation plans, risk assessments, test protocols, requirement traceability matrices, and summary reports for CQV activities.
- Leading commissioning, qualification, and validation of activities for technical systems.
- Providing guidance to project teams to ensure technical solutions align with validation plans and internal SOPs.
- Supporting additional tasks or projects as assigned by the supervisor.
Requirements
- Degree in Engineering or related field.
- Minimum 3 years of experience in CQV within pharmaceutical manufacturing.
- Hands-on experience with secondary packaging systems, including print and inspection technologies (e.g., Systech, Cognex).
- Proficiency in computerized systems validation.
- Strong understanding of GMP compliance and validation documentation.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
56916
Similar jobs
About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.