SDIampO Quality and Lab Systems Engineer/IT

Profile

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?

At Bristol-Myers Squibb, we believe that together we can make a difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.

As a quality and lab engineer in the Devens Digital Plant organization you will be working to support, enhance, and maintain compliance for the GxP benchtop instrumentation as well as site and global applications used within the quality and quality control organizations. This position requires a passion for IT and compliance by having a solid comprehension of data integrity principles and guidance as well as proven success in gap remediation. Project management and business analyst skillsets would be valuable within the role as the position requires the ability to work with diverse, cross-functional teams in a highly matrix organization.

Job Responsibilities:

Individual will provide direct support in the Devens Digital Plant organization for the data integrity program. This requires the ability to work with a diverse team to comprehend and map out the business process, identify gaps internally within the Devens site, and take action on the remediation of gaps.

Individual will liaison with global partners within the BMS organization to align on solutions and implementation plans.

Individual will provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as ViCell, SoloVPE, Cary60, and Spectramax plate readers throughout the site which would include laboratory (R&D and GxP) and manufacturing buildings.

Individual will provide local administrative support and liaison with global partners for the site quality systems (documentation system and quality management system) and quality control supporting applications (LIMS, Laboratory Execution System, NuGenesis, and Empower). This would include SOP driven activities which include, but are not limited to, application periodic reviews, user access reviews, and account administration.

Individual will maintain accuracy within the asset management tool for hardware, such as benchtop PCs and servers.

Individual will provide support for actions within the quality management system (Trackwise & Infinity) and support change requests, incident management, and problem management within Vitalize for assets that fall within the Deven Digital Plant Quality and Laboratory scope.

Individual will support creating, modifying, or archiving SOPs and Work Instructions, data flow maps, and application validation documentation as required.

Individual is responsible for managing small to medium size projects within a highly matrix organization.

Individual will collaborate with internal and external partners to provide compliant and technical solutions in a time sensitive environment.

Requirements:

BS degree in life sciences, engineering or computer field or equivalent experience.

Preferred 0-2 years of experience working in the BioPharma or similar industry with familiarity supporting benchtop instruments within a GxP compliant manufacturing or laboratory setting.

Comprehensive understanding of Data Integrity guidance, Software Development Life Cycle, and Good Documentation Practices.

Demonstrated leadership skills and the ability to negotiate in a complex environment.

Proven track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.

Excellent verbal and written communication skills.

The ability to plan and lead small and medium size projects and enhancements.

The candidate needs to be self-driven and capable of prioritizing.

The candidate should have a basic understanding of databases, servers, and PCs.

Familiarity with Waters’ Empower 3 and/or Waters NuGenesis, Biovia Lab Execution System (SmartLab), LIMS (e.g., SampleManager) Trackwise and Document Management System is preferred.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com