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.
PRINCIPAL OBJECTIVE OF POSITION: Describe the purpose of this position
Responsible to provide design guidance in projects towards changing the business. Assure adherence to technology and automation standards, as well as compliance requirements for automation, laboratories, applications, data gathering and analysis tools. Defines the architecture required to implement new information technology solutions. Performs recommendations for improvements to existing processes and systems with state-of-the-art computer technology. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
MAJOR DUTIES AND RESPONSIBILITIES:
Ensure that cGMP’s related computerized systems are properly maintained in accordance to all Federal, State and Corporate Regulations and therefore, supporting BMS’s business goals.
Works with the site’s Manufacturing, Engineering and Quality Operations Management in the assessment, recommendation, validation, implementation, and administration of new Computerized Systems (systems include and not limited to PLCs, HMI, Delta V, Factory Talk, SCADA, DCS/BAS, Batch Systems, communication interfaces, networking, printers, report engines, databases, business applications, and MES system).
Works with the engineering department in the planning, recommendation and implementation of new systems or enhancements to current systems. Collaborate with MS&T and Operational Excellence to execute data analytics related projects. Generates and maintains the Information Technology related Standard Operating Procedures (SOPs) related to projects design and automation standards.
Provides technical advice on the selection of equipment and system software for data acquisition, archival and other quality related systems. Participate in the installation, configuration, and qualification of IT infrastructure including Operating System and Applications.
Provides project status using project plans and perform best efforts to achieve projects milestones within the pre-established due dates.
Provides alternatives and problem solving initiatives during possible project delays. Coordinate and recommends action(s) to be taken whenever additions, alterations or changes are to take place in computerized systems.
Coordinates with Suppliers of hardware/software and services to obtain quotes and perform orders. Provides training to users on procedures, protocols and computer systems.
Assist on quality events investigations, internal audits, CAPA and standalone processes related Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems.
Evaluates and closes change control documentation assuring the validated and compliance state of the environments. Assist in the management of Capital Appropriation Requests (CAR’s) and timeline of process automation or laboratory systems projects and implementation of initiatives and solutions. Support in the execution of the Computer System Validation (CSV) program for automated and computerized systems processes. Keeps abreast with current technology.
KNOWLEDGE / SKILL:
• Five (5) years of combined experience in process automation or laboratory systems, information systems, and computerized systems validation.
• Two (2) years of experience in a designing role.
• Proven project management skills.
• In-depth knowledge of the science and computerized systems involved in the design, installation, commissioning and validation/qualification of computerized systems as applied to pharmaceutical production environment.
• Proficient knowledge of computer system development life cycle concepts, change control systems and FDA and EMEA regulatory requirements, including 21 CFR Part 11.
• Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
• Experience with external and internal regulatory audits.
• Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
• Broad experience in the design, development and implementation of infrastructure, MES and Quality Systems.
• General knowledge in applications such as: Maximo CMMS, QMS, DCA DMS, Data Historian and laboratory systems.
• Ability to manage and operate computer software packages used for data acquisition systems.
• Skilled with Microsoft operating systems and MS Office applications.
• Knowledge of Computerized Equipment/Operating Systems: Client Server environment, Windows, Relational Databases: Oracle, SQL, etc.
• Knowledge of OSI-PI highly desirable.
• Knowledge of SAP/R4 highly desirable.
• Knowledge of PLC , FT historian (Rockwell)
• Excellent communication skills (oral, written and reading) in Spanish and English.
• Able to interact effectively with people to establish and maintain excellent working relationships with internal and external customers at all organizational levels and disciplines in such a way to facilitate the assigned work.
• Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
• Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
• Self-starter and well organized and ability to keep work pace and/or meet deadlines.
• Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.
• Self-starter and well organized.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.