Lead, It Mes Operations

Lead, It Mes Operations
Empresa:

Bms


Lead, It Mes Operations

Detalles de la oferta

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients' lives through science. At the core of that mission are the talented individuals who contribute their "unique" skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team. What unique gene will you bring?

Accountable for the development of information technology strategy, guidance and support to the site manufacturing, quality operations, utilities and facilities systems. This includes operational strategy definition, planning, development, implementation and maintenance of systems pertaining IT and Automation areas of scope.
The position is specifically responsible to lead Syncade and automation operations support areas, assuring effective and compliance execution and documentation. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Job Description :
D evelops the site IT strategy for Manufacturing Systems design, integration and operational reliability as the strategic and operational partner to the Manufacturing, Quality Operations, Technical Services and Engineering Departments

Ensures the MES Operational Model is effective by implementing a proactive approach to issues prevention. The operational findings must be converted to corrective or preventive actions to assure an operational excellence culture.

Ensures the continued operations of Mission Critical Systems including development, validation, maintenance and support to the site manufacturing, utilities and facilities systems.

Lead and executes validation activities for systems in scope in collaboration with the Computer Systems Validation Function.

Coordinate and facilitate a process analysis and recommends improvements to existing processes using state-of-the-art computer technology.
Leads the operation and maintenance of Manufacturing Execution Systems, Quality Operations, automation, Engineering and Data Management applications.
Leads the Manufacturing Execution System applications as the administrator (Syncade, synTQ, OSI PI and SAP Interfaces).
Ensures the accuracy of the master data set up, system administration and security procedures.
Performs as the site liaison between manufacturing operations and headquarters Information Technology teams.
Ensures that the development of User Requirements, Specifications, Protocols, and procedures are aligned with site vision and BMS Policies and Procedures. Provides technical support for the execution of validation activities.
Develops and/or enhances the Syncade recipes and behaviors, to support all products within scope by providing specific and accurate request to the Global MES team.
Monitoring of manufacturing systems activities, subject to regulatory inspection, to assure high quality manufacturing operations.
Assures adherence to regulated agencies, site and TOIM Guidelines, Policies and Procedures.
Performs process analysis and recommends improvement (including automation) to manufacturing business scenarios. Participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology as well as on how these tools facilities systems integration and/or business requirement. Maintains the validated state of critical systems by managing systems security, performing and storing backups, and generating change control, as needed.
Installs, configures, troubleshoots, prototypes and maintains highly specialized computerized systems for the Manufacturing area.
Provides user training and continuous support to assure proper use of the software applications following established operational procedures as well as user support during problem solving situations associated in new business and/or manufacturing systems implementation.
Reviews computer related software applications or computer programs to ensure that Plant standards are met and that programs are capable of being integrated with other software applications as required.
Evaluates workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing computer operations.
Manages and/or assists Corporate and Plant Quality Assurance Audit groups in auditing for validation compliance and documentation of computerized system validations. Identifies, communicates, and recommends corrective actions to potential problems that are identified at these audits and ensures that appropriate management action is taken to correct these problems.
Assists Corporate, Plant, and Quality Assurance Management in providing and reviewing computerized systems validation documentation, plans and protocols with federal and local regulatory agencies.
Provides technical counsel on issues and concerns regarding validations plans and protocols design. Provides input on the design of specifications, and/or functional requirements for equipment facilities and systems. Provides expertise in corresponding business and automation during problem resolution activities.
Performs project management functions for the execution, implementation and start-up of new computerized systems.
Provides project status through the use of project plans and performs best efforts to achieve projects milestones within the pre-established due dates.

Requirements:
Bachelor Degree in Science (Chemical, Biology), Computer Science or Engineering (Electrical, Mechanical, Automation or Computer)
Minimum five (5) years' experience in computerized systems validation in a pharmaceutical manufacturing operations environment
Two (2) years' experience deploying and/or supporting Manufacturing Execution Systems (MES)
Proficient knowledge of system life cycle concepts, change control systems and FDA regulatory requirements

Proven experience issuing and preparing User/ Requirements, Design Specifications and Other Computer System Validation documentation using standards like GAMP 5, etc.
Knowledgeable of Solid Dosage Manufacturing business processes and technologies
In-depth knowledge of the science involved in validation/qualification and integration of computerized systems as applied to pharmaceutical production environment
In-depth knowledge of local/federal regulatory requirements, and documentation procedures (e.g., CGMPs, SOPs, etc.) pertaining to a pharmaceutical manufacturing operation
Proven skills in projects management, systems development and implementation of manufacturing and quality related systems
Knowledge of SAP/R3
Ability to manage and operate computer software packages used for data acquisition systems
Knowledge on databases and of different control system network protocols (e.g. Control Net, DeviceNet, Fieldbus, etc.)
Excellent oral and written communication skills in both English and Spanish

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 the resources to pursue their goals, both at work and in their personal lives.


Fuente: Neuvoo1_Ppc


Área:

  • Otros / Otros

Requisitos


Conocimientos:

  • Utilities
  • OSI

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