CSV Engineer – Process & Operations Support

Location: Oss, Noord-Brabant  |  Sector: Biotechnology  |  Start Date: 11/20/2024  |  Job ref: 53938

The Company
Our client is a global organization committed to advancing women’s health at every stage of life. Their team is driven by a shared passion for making a meaningful impact on well-being, with a deep sense of pride in their contributions. Are you also ready to be part of this extraordinary team?
The role
In this role, you will play a key part in a variety of dynamic and demanding projects across multiple production departments. You will support internal clients by helping to create change management plans, recommend validation strategies, and take responsibility for drafting and managing essential validation documentation
Responsibilities
-Develop a detailed plan for validating systems and processes.
-Document the needs and expectations of the system’s end users.
-Create strategies and procedures for system testing.
-Summarize test results and ensure compliance.
-Verify that designs meet functional and regulatory standards.
-Provide a final overview of the validation process and outcomes.
-Lead projects and encourage team collaboration
Requirements
- Technical education (min. HBO) and 5+ years in Automation (CSV/software/PLC/SCADA). 
- Proven leadership in projects and experience with GAMP5. 
- Service-oriented, proactive, with strong Data Integrity knowledge. 
- Familiar with Life Sciences/Pharmaceuticals, cGMP, safety, and validation. 
- Strong English communication skills and experience with change management tools (TrackWise, EtQ). 

53938

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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.