CSV Engineer

Hobson Prior are currently seeking a CSV Engineer to join an international healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. You will join them in their offices in Switzerland on a 12-month contract basis.

Job Responsibilities:

• Information Technology Requirements, GmP Regulation, must be explained and obtained from the vendor of system.
• When necessary, the Engineer, may have to customize the system, or adapt the process, to comply the GmPs.
• Guarantee Data Integrity of the system into its environment and process.
• Design through elicits, analyzes, documents, and validates detailed user / functional / non-functional requirements; identify gaps between system capabilities and requirements to ensure that business needs are met.
• Adjust the number of deliverables, their quality and complexity to guarantee the respect of timelines and fit to validation approach.
• Facilitate meetings with business colleagues on IT topics.
• Assist the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (IQ, PQ,FAT).
• Understand business objectives, processes, and strategies.
• Drive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications.
• Ability to work strategically and independently with internal and external groups on multiple simultaneous projects.
• Understand and ensure the use of existing standards for design and governance.
• Architect system specific topology and adapt/integrate it into existing infrastructure.

Key Skills:

• Fully operational in French and English.
• Business acumen.
• Autonomous in analysis, problem solving and achieving deliverables.
• Oral and Written communication.
• Constructive influencing of colleagues to positive outcome.

Requirements:

• Widespread IT technical knowledge such as Operating System, Infrastructure and Networking. Programming is excluded and development of script is very limited.
• Proficiency into Computer System Validation in the pharmaceutical environment is required.
• Pharmaceutical, Biotechnology, Life Science industry experience is a must.
• A minimum of 3-5 years' experience as an IT Engineer running project from requirements to delivery of final product and documentation included.
• Familiar with Change Management tools and regulated document authoring.
• COTS and Web-based requirements, architecture, Agile/SCRUM methodology.
• Real Time Data Management and Interfaces (e.g.: Kepware, OSI PI) a strong plus.
• Serialization technologies (Laetus) a strong plus.
• Six Sigma, Lean or Business Process Change Techniques a plus.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.