IT Engineer

For our client, a leading and innovative pharmaceutical company with its international headquarter based in the French part of Switzerland, we are searching for an

1 year contract

The candidate should have widespread IT technical knowledge, including Operating Systems, Infrastructure, and Networking. Programming is not required, and scripting is very limited. Proficiency in Computer System Validation (CSV) within the pharmaceutical environment is necessary.

This position will be responsible for improving or fully implementing off-the-shelf and configurable systems (Gamp 3 and 4), both standalone and interconnected, regulated by GmPs. Additionally, they will occasionally collaborate on global/interconnected systems (Gamp 5)

Your main tasks

• Explain and obtain IT requirements and GmP regulations from system vendors. Customize systems or processes as needed to comply with GmPs.
• Ensure data integrity within the system and its processes.
• Design and document detailed user and system requirements, identifying gaps to meet business needs.
• Adjust deliverables to meet timelines and validation approaches.
• Facilitate IT-related meetings with business colleagues.
• Translate compliance requirements into test conditions and results for application functionality and acceptance testing.
• Lead change management and training during system implementation and use.
• Ensure the use of existing design and governance standards.
• Architect and integrate system topology into existing infrastructure.
• Collaborate with IT groups to apply technological standards.
• Implement standalone and interconnected systems for production and quality control activities.
• Configure systems, implement backups, and deploy privileges on operating systems and file systems.
• Develop governance and work practices for system support and administration.
• Coordinate with specialists for global network, backup, and infrastructure configuration.
• Set up local networks, infrastructure, computers, and applications.
• Prepare and configure interfaces between multiple systems using Kepware technology and OPC protocol.

Your profile

• Experience in the Pharmaceutical, Biotechnology, or Life Science industry.
• 7+ years as an IT Engineer managing projects from start to finish.
• Technical diploma in Information Systems or equivalent experience.
• Experience in Computer System Validation.
• Knowledge of Change Management tools and regulated document authoring.
• Familiarity with COTS, web-based requirements, architecture, and Agile/SCRUM.
• Experience with Real-Time Data Management and Interfaces (e.g., Kepware) is a plus.
• Proven experience with Aveva-PI suites and Building automation systems (Desigo, RMS Rotronic) is a plus.
• Knowledge of Six Sigma, Lean, or Business Process Change Techniques is a plus.
• Awareness of 21-CFR Part 11, Eudralex, and MHRA regulations.
• Understanding of business and enterprise architecture.
• Strong business acumen and ability to work independently in analysis, problem-solving, and achieving deliverables.
• Excellent oral and written communication skills with ability to positively influence colleagues.
• Proficiency in French and English.

Raya Röösli is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).
Full discretion is guaranteed, and we will gladly answer any additional questions.