\\n Region Westschweiz

Bereich IT

Online seit 22.09.2023

Referenz 2304

Our client is a leading and innovative pharmaceutical company with its international headquarter based in the French part of Switzerland.

IT Manufacturing Engineer C&Q

2-year assignment starting January 2024

In this role you are responsible for the improvement and full implementation of the off-the-shelf and configurable (Gamp3 and 4) standalone and interconnected standalones, regulated by the GmPs.

Your main responsibilities

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.

Assist the translation of compliance requirements into test conditions and expected results for application functionality, and acceptance testing (IQ, OQ, PQ, FAT, SAT)

FAT would be in EU countries

Drive development and execution of change management and training throughout the organization during the implementation and ongoing use of system applications

Define new versatile solutions covering abstract User Requirements to fulfill unmet needs.

Implement specific standalone and interconnected computerized system supporting activities like Production (Blending, Encapsulation, Tablet Press, Blistering, Bottling, Room Monitoring System and other various equipment used for the manufacturing.

Usage of a wide variety of Information Technology skills to configure systems, implement backup mechanism for flat files, databases, etc. Deploy proper privileges on Operating System (Windows) and File Systems.

Develop governance and \\xe2\\x80\\x9chow to\\xe2\\x80\\x9d Work Practices, including their Configuration Specifications to allow the operational team to support and administer the newly integrated system.

Transmit information and follow up with specialists to obtain required configuration of the global network, backup tool and infrastructure.

Configure and setup local network, infrastructure, computers and applications.

Preparation and configuration of interfaces between multiple system may be required. Usage of Kepware technology and OPC protocol will be required.

Your Qualifications

Pharmaceutical, Biotechnology, Life Science industry experience is a must.

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

Six Sigma, Lean or Business Process Change Techniques a plus

Technical diploma in Information Systems or equivalent experience

Experience in Computer System Validation

Awareness of 21-CFR Part 11, Eudralex, MHRA

Awareness of business and enterprise architecture

Fully operational in French and English

Tamara Godenzi is looking forward to receiving your application:

reference number: 2304

by mail to or through our website .
Full discretion is guaranteed and we will gladly answer any additional questions.\\n \\n \\n \\n \\n \\n

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