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Senior Specialist, IT Manufacturing Phoenix, Phoenix, Arizona

CategoryInformation Management
Job typeFull-Time
CountryUnited States

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.

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.

Responsibilities include, but are not limited to:

The primary working location is Phoenix and might include other BMS plants as required.

Requirements are, 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 candidate is the improvement or full implementation of off-the-shelf and configurable (GAMP 3 and 4) standalone and interconnected systems, regulated by GxP. To a lesser extent, (s)he will collaborate on (GAMP 5) worldwide/interconnected systems.

  • Information Technology requirements; ensure that vendor provided systems meet GxP requirements. When necessary, the Engineer, may have to customize the system, or adapt the process, to comply the GxP regulations.
  • Ensure Data Integrity for all system implementations.
  • Design from gathering, analyzing, documenting, and validating detailed user / functional / non-functional requirements; identify gaps between system capabilities and requirements to ensure that business needs are met.
  • Manage deliverables in terms of quality and complexity while ensuring meeting timelines including appropriate 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, PQ, FAT).
  • 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 Business Partners and other IT Groups on defining site future digital strategy.
  • Use existing standards where possible to leverage synergies.
  • Implement standalone and interconnected computerized system supporting activities in production (i.E.: Serialization, sterile manufacturing, inspection, room monitoring systems as well as equipment used in manufacturing, packaging and Quality Control of drug products).
  • Usage of a wide variety of Information Technology skills to configure systems, implement backup mechanism of flat files, databases, etc. Deploy proper privileges on windows based operating systems (Windows).
  • Develop governance and "how to" work practices, including their configuration specifications to allow the operational team to support and administer the newly integrated system.
  • Configure and setup local network, infrastructure, computers and applications.
  • Preparation and configuration of interfaces between multiple systems may be required. Knowledge of the OPC protocol is highly desired.

Skills/Knowledge Requirements :
  • 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 controlled document authoring.
  • Knowledge of COTS and web-based applications, architecture, Agile/SCRUM methodology.
  • Understanding of Manufacturing Execution Systems (MES).
  • Real Time Data Management and Interfaces (e.g.: Kepware, OSI PI) a strong plus.
  • Serialization technologies (Laetus) a strong plus.
  • Six Sigma, Lean or Business Process Change Techniques a plus.

Functional Knowledge:
  • BS degree in Information Systems or equivalent experience
  • Experience in Computer System Validation
  • Awareness of 21-CFR Part 11
  • Awareness of business and enterprise architecture

Position Skills :
  • Business acumen
  • Self-sufficient in analysis, problem solving and achieving deliverables
  • Oral and Written communication
  • Constructive influencing of colleagues to achieve positive outcomes

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.
EmployerBristol-Myers Squibb

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