Equipment Validation Engineer

Location: Groningen, Groningen  |  Sector: Biotechnology  |  Start Date: 6/11/2024  |  Job ref: 52880

The Company
Our client is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden hard-working and multiscale people are working in a high-performance culture in which innovation and a 'can do' state of mind are the central points.

Role Description
As an experienced Equipment Validation Engineer to handle equipment implementation and validation. You will work closely with engineering teams as a process technology and equipment validation expert to meet design, quality, and business goals.

– Collaborate with Subject Matter Experts (SMEs) to write technical protocols and perform validations.
– Gather requirements, user stories, and specifications; write User Requirements Specifications (URS), Test Matrices (TM), Factory Acceptance Tests (FAT), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) for machines, equipment, and software components.
– Develop and execute test protocols, and document the results in detailed reports.
– Manage deviations and defects, and communicate with the Validation Review Board (VRB).
– Coordinate and support departments such as R&D, Quality Assurance (QA), Operations, and external suppliers, ensuring alignment with project deliverables.

– 4+ of experience in a Manufacturing or Industrial Engineering role within medium to high volume production environments.
– Proven experience in a highly regulated industry with a strong understanding of cGMP.
– Demonstrated hands-on approach and ability to collaborate effectively with all teams.
– Proficient in ICT tools, including Microsoft Office and Minitab.
– Extensive experience with validation processes in medical device, pharma, or other highly regulated sectors.

Other Information
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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.