CSV Engineer (m/f/d)

Job Description

The CSV Engineer (m/f/d) will operate with the Orise project teams in performing GxP Computerised Systems CSV activities for several projects.

Main Responsibilities & Duties:

• Management of client CSV activities and relationships
• Working as part of client project teams to define CSV strategy for projects
• Preparation/testing of validation protocols, and all associated documentation for GxP Computerised Systems.
• Support the operation of systems by executing Periodic Reviews, Change Controls and Audit Trail Reviews.
• Provide assistance with the generation of CSV related documentation.

  Act as Process Champion taking ownership of internal processes to continually develop and improve them as part of the company continual improvement process; be the ‘go-to’ person for the designated process (s)

• Develop and maintain designated client site expertise to enhance the relationship and efficiency between Orise and respective client.
• Working as part of Orise and client teams in the development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab, Automation, Business and Equipment systems.
• Review/Approval of all GxP Computerised Systems Validation Documentation.
• Administration of GAMP lifecycle across concurrent projects.
• Any other duties which may be assigned from time to time.

Essential

• Have excellent communication and interpersonal skills, both written and verbal
• Have the ability to communicate IT/Validation concepts/strategies to project teams.
• Be a self-starter and be motivated to provide a solid product quality and customer experience.
• Be organised and adaptable to a fast pace working environment
• Be able to integrate and interact well within the customer environment.
• Have excellent Microsoft Office user level skills

Desirable

• Strong knowledge of Quality Management System Processes i.e., change control, CAPA, deviation

Education & Experience:

• A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 5 years’ relevant experience).
• A minimum of 3 years CSV experience in the Life Sciences sector
• Detailed knowledge of regulatory guidance documents and standards

Additional Information

Disclaimer on the Use of AI in our Recruitment Process

To ensure our hiring process is fair, ethical, and transparent, ATS incorporates the use of AI technologies to enhance the recruitment process. We utilize Microsoft CoPilot to assist with the development and posting of job descriptions and assist with recruitment administrative tasks. The software uses pre-defined, rule-based filters which operate on fixed criteria and do not perform autonomous evaluation or generate independent recommendations. Microsoft Team Transcript is used to capture and document candidate interviews. Prior to the start of any interview, you will be asked if you consent to the use of transcript. The decision is yours and it will be honored by ATS.

The use of AI within our recruitment process is governed by the following core principles:

• Human Oversight and Accountability - AI is used solely to augment, not replace human judgment. All decisions regarding CV/resume screening, who to interview, and who to hire are made by ATS hiring managers and recruitment teams.
• Transparency and Data Protection - ATS will inform candidates when AI is being used to transcribe an interview to ensure our notes are complete and accurate. Candidates may choose whether or not to allow the use of transcript. All applicant data, including AI-generated interview notes, is treated as a confidential recruitment record and managed in accordance with applicable data protection laws.
• Fairness and Equality - ATS is committed to ensuring the use of AI is vetted and assessed to ensure it is not creating or perpetuating bias or discrimination.