The Company
The company is a global American women’s health and fertility pharmaceutical pioneer.
Role Description
The CSV Specialist will be part of the Business Technology department at the Oss location, contributing to a range of challenging projects within various production departments. In this role, you will guide internal teams in developing change management plans, propose validation approaches, and create essential validation documentation. You will also lead projects and work closely with cross-functional teams, ensuring that all documentation is in compliance with industry standards.
Responsibilities
- Leading the creation of key validation documents, including validation plans, user requirement specifications, test plans, test scripts, test summary reports, design qualification matrices, and validation summary reports.
- Acting as a project lead on specific projects, managing timelines and teams.
- Supporting internal clients in change management processes and defining the validation approach for various projects.
- Collaborating with other teams and ensuring the alignment of validation processes with regulatory and industry standards.
- Ensuring adherence to data integrity requirements throughout the validation process.
- Continuously contributing to improving systems and processes within the Business Technology department.
Requirements
- A completed technical education at a minimum of HBO level.
- At least 5 years of experience in Automation, specifically as a CSV/software/PLC/SCADA Engineer.
- Proven experience in leading projects.
- Strong familiarity with GAMP5 (Good Automated Manufacturing Practice).
- Service-oriented with a “go-see” attitude.
- Solid understanding of data integrity requirements.
- Experience in Life Sciences or Pharmaceuticals, with knowledge of cGMP (current Good Manufacturing Practices), safety standards, and validation processes is preferred.
- Experience with change management tools such as TrackWise or EtQ.
- Familiarity with pharmaceutical systems is a plus.
- Strong communication skills in both English (mandatory) and Dutch (preferable).
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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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.
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