Senior Specialist, IT Manufacturing Boudry

Bristol Myers Squibb (Boudry, Schweiz) Vor 6 Tagen veröffentlicht

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The primary working location is Boudry and might include other BMS plants in Switzerland as and when required.

Requirements are, 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.

In this role, you will be responsible in the improvement or full implementation of off-theshelf and configurable (Gamp3 and 4) standalone and interconnected standalones, regulated by the GmPs. To a lesser extent, you will collaborate on (Gamp5) worldwide/interconnected systems.

Responsibilities:

  • Information Technology Requirements , Ensure that vendor provided systems meet GxP requirements. 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.
  • Collaborate with IT Business Partners and other IT Groups on defining site future digital strategy.
  • Use existing standard to capitalize on lessons learned.
  • Define new versatile solutions covering abstract User Requirements to fulfill unmet needs.

  • Implement specific standalone and interconnected computerized system supporting activities like Production (e.g.: Track & Trace, Blending, Encapsulation, Tablet Press, Blistering, Bottling, Cartoning , 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 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 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 OPC protocol will be required.

Skills/Knowledge Requirements:

  • Pharmaceutical, Biotechnology, Life Science industry experience is a must.
  • Minimum 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.
  • Understanding of Manufacturing Execution Systems (MES).
  • 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

Functional Requirements :

  • 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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.


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Senior Specialist, IT Manufacturing Boudry

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