For our client a global pharmaceutical company, we are looking for an industrial IT engineer consultant.
The Company
Our client is a global biopharmaceutical company located near Neuchatel, Switzerland. Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, haematology, immunology, and CVD
The Role
The IT engineer will be involved in improving or fully implementing off-the-shelf and configurable (Gamp 3 and 4) standalone and interconnected standalone, regulated by GmP. To a lesser extent, he/she will collaborate on (Gamp 5) worldwide/interconnected systems. He/she will have widespread IT technical knowledge such as operating systems, infrastructure and networking and proficiency in computer system validation in the pharmaceutical industry. Programming is excluded and development of script is very limited.
Duties and Responsibilities:
Information Technology Requirements, GmP Regulation, must be explained and obtained from the vendor of the system. When necessary, the Engineer may have to customize the system, or adapt the process, to comply with the GmPs.
Guarantee Data Integrity of the system in 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 the 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, OQ, PQ, FAT, SAT)
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.
Collaborate with IT groups to ensure standards are applied for technological tools.
Use existing standards to capitalize on lessons learned.
Define new versatile solutions covering abstract User Requirements to fulfil unmet needs.
Implement specific standalone and interconnected computerized systems supporting activities like Production (e.g.: Blending, Encapsulation, Tablet Press, Room Monitoring System) and other various equipment used for the manufacturing, packaging, and Quality Control of drug products.
Usage of a wide variety of Information Technology skills to configure systems, implement backup mechanism for flat files, databases, etc. Deploy proper privileges on the Operating System (Windows) and File Systems.
Develop governance and “how to” 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 the required configuration of the global network, backup tool and infrastructure.
Configure and set up local network, infrastructure, computers and applications.
Preparation and configuration of interfaces between multiple systems may be required. Usage of Kepware technology and OPC protocol will be required.
You:
Our client is looking for someone who has the following skills and knowledge:
Pharmaceutical, Biotechnology, Life Science industry experience is a must.
8-10 years' experience as an IT Engineer running projects 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…) a strong plus.
Proven experience in the installation and qualification of Aveva-PI suites is a strong plus.
Proven experience in the installation and qualification of Building automation systems (Desigo, RMS Rotronic) is 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.
Business acumen.
Autonomous in analysis, problem-solving and achieving deliverables.
Oral and Written communication.
Constructive influencing of colleagues to positive outcomes.
All applicants must be authorised to work in Switzerland and be of Swiss nationality or have a valid Swiss working permit.
Please contact recruitment@consultantsinscience.com to apply