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.
PURPOSE AND SCOPE OF POSITION:
Digital manufacturing is a sub-organization within global product development and supply (GPS) IT organization. The digital manufacturing team’s primary role is to develop and deliver digital solutions for Manufacturing and laboratory at various BMS sites of all modalities, with focus areas of:
We also set standards that drive the organization to a harmonized digital implementation.
Enterprise Manufacturing Execution Systems (EMES) is utilized globally within BMS across the digital manufacturing network to produce medicine. The EMES Recipe Lead for digital manufacturing is primarily responsible for development, testing, maintenance and support of the recipes used to manufacture medicine within different sites that are part of cell therapy, Biologics, Pharma and Biosterile operating units. The EMES Recipe Lead’s scope is executing the global recipe management strategy that includes managing the Business units/operating unit/network-based recipes, from requirements,build, testing and support of recipes, managing reports, and any customizations that support business unit manufacturing and batch disposition operations.
This is technical and people manager role with key focus on technical delivery with the team.
This leader will also provide day-to-day management necessary to drive the deliverables for EMES recipes used across multiple BMS sites. This leader will also provide technical direction, remove any barriers for the team to meet the delivery objective and collaborate with US, EU based recipe leads and development teams.
This leader ensures that team is operating consistently and effectively within established ways of working for managed capabilities among US, EU and BMS India based EMES team. The leader will work with business partners, CSV team, senior leaders and engineers, influence and drive EMES vision. This role will report into Delivery Lead, Digital Manufacturing GPS IT for BMS India and will also have indirect reporting into US based EMES delivery leader.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Ability to effectively communicate with both technical and non-technical team members.
Ability to manage project and support, and technical team (size ~12)
Ability to interact with technical leadership, solve complex technical problems, translate business requirement into executable recipes.
Strong interpersonal skills, especially regarding:
Teamwork and collaboration
Delivery and Customer focus
Verbal and written communication
Strong technical judgement, influence, problem-solving, troubleshooting, and decision-making skills
Demonstrated ability to lead the implementation of recipes in multi-site global manufacturing network for manufacturing execution systems.
Knowledge of industry standard integration protocols and programming applications such as OPC, BACNet, ODBC, SQL and Web API.
Knowledge of system architecture principles and Purdue reference model and programming applications such as OPC, BACNet, ODBC, SQL and Web API.
Knowledge and experience with MES, preferably Emerson Syncade.
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
Working knowledge of S88 and S95 standards in relation to process automation and manufacturing execution.
Demonstrated success working in a high-performing, business results-driven environment.
Familiarity with Business Intelligence (BI) and reporting programs including Infobatch and similar tools.
Understanding of computer system validation.
Ability to travel up to 10% domestically and internationally
Ability to work across global sites and cultures.
A passion for people management and mentorship.
Education and Experience:
Bachelor of Science in Engineering, Computer Science or related fields with 8+ years’ Life Sciences industry experience and at least 3 years’ experience in Emerson Syncade MES
At least 6 years’ direct experience in designing and building recipes in automation and execution systems (Syncade, DeltaV, PI Data historian, etc.) in regulated manufacturing environments
Minimum 3 years of experience attracting, hiring, maintaining and managing employee talent.
Strong domain expertise in the application of IT to manufacturing, including a broad understanding of processes and how they are supported by IT tools and systems.
Strong knowledge of regulatory landscape and demonstrated experience with software validation.
Proven track record of successful IT/automation project delivery
Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g., Oracle, SAP).
Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
Must have prior experience of working with teams across the globe-US and EU.
DUTIES AND RESPONSIBILITIES:
Partner with business functions, recipe authors, CSV,validation to understand requirements for electronic batch record.
Define, manage, and deliver the project roadmap for recipe delivery to support changing/emerging technologies and the continuing maturity of digital manufacturing
Define requirements for building blocks required for recipe functionality for process automation
Establish standards for recipe buildout and recipe architecture for various operating or business units.
Partner with SAP,LIMS,CMMS,middleware,Oracle and other application integration teams to manage and deliver updates to the recipes.
Build, Manage and support the recipes and workflows that enable EMES maturity and deliver enhancement and defect updates per business priority
Ensure recipes and its associated data are designed around simplicity, flexibility, and cost effectiveness
Establish and oversee recipe benchmarking metrics and strategy to gauge recipe performance around user and system and identify improvement opportunities
Lead recipe delivery process including
Partnering with Supply Chain, MS&T, Quality, and Manufacturing Operations to understand business requirements
Development of functional specifications
Recipe authoring, demos and dry run facilitation
Recipe User Acceptance Testing
Recipe and master data installations and promotions
Lead label (inventory, sample, drug product etc..) requirements gathering, development and delivery process
Perform recipe and specification review and approvals
Partner with MS&T and Quality to understand requirements and opportunities around batch disposition and Review by Exception and Release by Exception strategies
Tier 3 escalation support of recipes and process to minimize disruption to manufacturing and/or impact to product
Manage a recipe authoring and testing team to deliver on-time and on-budget projects
Define and manage strategy for collecting end user feedback and improving the usability and user experience of the overall EMES solution.
Support risk and impact assessment that changes, patches, outages or other events can have to the EMES solution and the global network and define mitigation strategies
Support a knowledge management strategy including generating training content and mentoring
Promote compliance with data integrity and computer system validation requirements and regulations
Promote compliance by understanding change and the impact to the validated state of the application and underlying infrastructure.
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 Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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