Computer System Validation Professional for Confidance® Validation Services

Computer System Validation (CSV) Professional Join Sartorius as a Senior Computer System Validation (CSV) Professional and become a key player in driving harmonization, compliance, and quality assurance within our Confidence® Validation Services Quality team. In this impactful role, you will lead the establishment of a harmonized validation policy, ensuring our computer systems are compliant with the latest regulatory standards (e.g., 21 CFR Part 11, OECD 17, OECD 17 supplement 1, EU-GMP Annex 11). Your expertise will be instrumental in implementing state-of-the-art tools such as an eQMS and ELN/LIMS, enhancing our service department's efficiency and quality. Additionally, you will have a chance to elevate our quality assurance processes by driving the implementation of an eQMS as well as to contribute to the global harmonization across all Confidence® Validation Services sites. This full-time hybrid position offers the flexibility of remote work while requiring some on-site presence to foster collaboration and innovation.

**Your Key Responsibilities**
- ** Lead the Development and Implementation**: Spearhead the creation and execution of a comprehensive computer system validation policy, ensuring alignment with current regulatory standards (e.g., 21 CFR Part 11, OECD 17, OECD 17 supplement 1, EU-GMP Annex 11, GAMP 5) for Confidence® Validation Services.
- ** Drive Global Electronic Systems Initiatives**: Lead the implementation of new global electronic systems, such as an eQMS, ensuring seamless integration and compliance.
- ** Post-Implementation**: Manage the ongoing maintenance and updates of electronic systems, ensuring optimal performance and compliance.
- ** Risk Assessment and Compliance**: Conduct risk assessments, compile compliance reports, manage deviations, and ensure all documentation meets quality and regulatory standards.
- Create and oversee CSV protocols, including IQ, OQ, and PQ, ensuring thorough validation of electronic systems.
- Oversee the document lifecycle, from creation and revision to storage
- Support administration of electronic systems ensuring efficient operation
- Offer basic CSV training to enhance team capabilities and ensure compliance
- Collaborate intimately with all stakeholders to guarantee systems comply with project and regulatory standards
- Participate in regular project meetings to align with system owners and management, ensuring project requirements are met and issues are resolved.
- Supervise vendor interactions, including reviewing and tracking vendor deliverables and system qualifications
- Collaborate with global/regional site quality units and functions to ensure harmonized practices
- Any ad hoc duties to collaborate and contribute to other activities as identified Confidence® management

**What will convince us**
- ** Advanced Educational Background**: Master's degree or higher in a relevant field (e.g., Engineering, Computer Science, Life Sciences)
- ** Industry Experience**: Minimum of 5 years in a GMP and/or GLP-regulated environment, with a proven track record in validating cloud solutions such as eQMS, LIMS/ELN, and stand-alone computer systems.
- ** Regulatory Expertise**: Extensive knowledge of CSV regulatory requirements (e.g., 21 CFR Part 11, OECD 17, OECD 17 supplement 1, EU-GMP Annex 11, GAMP 5).
- ** Independent Deliverable Generation**: Ability to independently generate CSV deliverables, ensuring high-quality outputs.
- Experience in working in a cross-cultural set up
- Ability to develop realistic work plans, set personal goals that align with company goals
- Superior organizational, communication, and documentation skills
- Self-driven and methodical way of working, ensuring thoroughness and accuracy
- Fluent in English, with excellent communication skills