Digital Capability Manager
vor 3 Wochen
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.
Widespread IT technical knowledge such as Operating System, Infrastructure and Networking. Programming is excluded and development of script is very limited. Proficiency in Computer System Validation in the pharmaceutical environment is required.
The accountability of the worker is the improvement or full implementation of off-the-shelf and configurable (Gamp3 and 4) standalone and interconnected standalones, regulated by the GmPs. To a lesser extent, he will collaborate on (Gamp5) worldwide/interconnected systems.
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: Elicit, analyze, document, and validate 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, 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 fulfill unmet needs.
- Implement: Specific standalone and interconnected computerized system supporting activities like Production (e.g.: Laetus 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 mechanisms 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 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.
Skills/Knowledge Required
- Pharmaceutical, Biotechnology, Life Science industry experience is a must.
- 3-5 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.
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