Principal Specialist, E-Systems

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.

Competences

In this position the E-Systems Principal Specialist manages the business perspective of strategy, development, interfaces, change management and maintenance of Globally managed E-Systems used within and by GMO for their end to end operations from process, system and execution aspects.

This mission will be led in close collaboration with all GMO manufacturing sites and key stakeholders in Production, Quality Control, Information Technology (IT), Quality E-Systems, Quality Assurance, GSC as well as other Global departments.

The E-Systems Principal Specialist can act as a back-up within the E-Systems and NS&BO department.

Duties and Responsibilities

• Globally manage manufacturing E-Systems:
  • Act as a point of contact for new business requirements/enhancements in Phoenix manufacturing site
  • Ensures holistic approach in system related initiatives
  • Coordinates and participates in BMS systems integration initiatives
  • Provides business operations impact analysis from systems and interfaces perspective
  • Oversees coordinating change management activities from the business side, in cooperation with site leadership / representatives and IT functions
  • Ensures proper documentation (Functional Specifications, User Requirements definition, Test Scripts) as author and/or reviewer
  • Is business point of contact for UAT planning and execution
  • Defines and enables training as per requirements
• Leads UAT strategy, organization, planning, preparation and execution for Phoenix site for all functionalities
• Ensures all activities are executed in compliance with GxP regulations
• In charge of process definition and improvement, SOP and WP management for the scope of his/her area
• Ensures the KPIs of his/her activities are defined and met as per targets
• Ensures CAPA and CCRs of his/her scope are timely defined, implemented and executed
• Acts as a project team-member or lead for Systems related projects in his/her scope
• Communicates pro-actively and consistently and coordinates with the different stakeholders
• Supports IT and QA investigations as required
• Supports Validation activities related to globally managed manufacturing E-Systems in collaboration with IT, Site Technical Services and MS&T

EHS

• Respects and implements EHS rules and promotes safe practices and behaviors
• Works with EHS to evaluate hazards and perform risk analysis
• Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future

Skills/Knowledge Required

• 7+ years' experience in the field of ERP, MES (or other computerized and automated systems) management in the domain of Manufacturing
• BA or BS/MS degree in Computer Science, Life Sciences or equivalent
• Knowledge of the pharmaceutical environment and cGxP-experience
• Excellent ability to understand business needs and translate them to Business Requirements
• Excellent understanding of impact and consequences on business operations and cross-functional areas for data and system features
• Capability to define, coordinate and steer execution of user-testing related to operations performed on manufacturing site
• Knowledge and experience in computerized system implementation and validation
• Project management knowledge and/or experience
• Capability to work in a changing environment and beyond pre-defined processes and to actively contribute to improvements
• Strong team-player
• Excellent negotiation, organization, communication, problem-solving skills
• Pro-active personality with an eye for anticipation and consequence management
• Conscientious, reliable in action follow-up
• Excellent IT proficiency: MS Office, ERP - Oracle, SAP, Syncade experience is an asset
• Experience in System interfaces and data management is an asset

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.