The Company
Our client is a multinational biotech company who strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.
Role Description
As a CSV Engineer, you will be responsible for ensuring that computerized systems used in GMP-regulated environments are validated in compliance with applicable regulatory requirements. You will lead or support validation efforts across the lifecycle of systems, including laboratory equipment, manufacturing systems, and quality systems software.
Responsibilities
- Develop, review, and execute validation deliverables (e.g., URS, Risk Assessments, IQ, OQ, PQ, validation plans and reports)
- Ensure systems are validated in accordance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and company policies
- Collaborate with IT, QA, and system owners to implement and maintain validated systems
- Support audits and inspections by providing documentation and responding to questions on validation activities
- Maintain validation documentation and ensure data integrity compliance
- Provide guidance on change control, periodic reviews, and system lifecycle management
- Participate in project teams for new system implementations or upgrades
Requirements
- Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field
- 2–5 years of experience in Computer System Validation in the pharmaceutical or biotech industry
- Strong knowledge of applicable regulatory standards
- Experience with GMP environments and validated systems (e.g., LIMS, MES, ERP, SCADA)
- Analytical mindset with strong documentation and organizational skills
- Fluent in English (spoken and written); Dutch is a plus
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
55139
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.