Job Detail
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Job-ID 332322
Job-Beschreibung
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: .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.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 system. 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, 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 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.: 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 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 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 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…) 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 outcome
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.