Bristol Myers Squibb Lab and Quality Systems Engineer in Devens, Massachusetts
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.
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. 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.
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 include laboratory and manufacturing buildings.
Support administration of quality and laboratory applications including their software development life cycle activities and technical support.
Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
Lead or provide supporting activities within the quality management system (Trackwise & Infinity)
Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training.
Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration.
Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
Ensure alignment with BMS directives and industry guidelines for applications.
Execute on technology improvements and efficiency opportunities to improve business and compliance.
Provide on-call support, as needed, for 24/7 commercial operations.
BS degree in life sciences, engineering or computer field or equivalent experience.
Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
Demonstrated leadership skills and the ability to negotiate in a complex environment.
Demonstrated 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 an expanding understanding of network, databases, servers, and PCs.
Understanding of administration and usage of with Waters’ Empower and/or Waters NuGenesis, Biovia Lab Execution System (SmartLab), LIMS (e.g., SampleManager) Trackwise and Document Management System and emerging technology is preferred.
Developed system and business analysis skills
Ability to apply lean and OpEx principles.
Project management, communication, and technical writing skills are required.
The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers .
The above statements are intended to describe the general nature of work being performed by people assigned to these roles. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
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.
Company: Bristol Myers Squibb
Req Number: R1534253-en-us
Updated: 2021-03-02 00:29:49.080 UTC
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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