Engineer, IT Compliance, Lab and Quality Systems

Bristol Myers Squibb-posted 4 months ago

$87,000 - $102,000/Yr

Full-time • Entry Level

Hybrid • Devens, MA

5,001-10,000 employees

Chemical Manufacturing

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The overall focus of this resource will encompass the following: laboratory and manufacturing instrument PC support and application administration, local support and liaison for global laboratory and quality systems, and administrator for local laboratory and quality systems. The resource will integrate information from the end user and in collaboration with matrix teams within BMS to understand opportunities for investigating and implementation of existing and emerging technology in accordance with applicable regulations and BMS approved policies and procedures.

Execute, update, and support staff on documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
Utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems with limited guidance and provide ownership of assets.
Executes and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
Provides digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defends their work before regulatory agencies.
Ensures alignment with BMS directives and industry guidelines for applications.
Execute on technology improvements and efficiencies opportunities to improve business and compliance.
Providing on-call support, as needed, for 24/7 commercial operations.
Support Quality and Manufacturing areas during audit and inspections from internal and external organizations.
Work both independently and in a team environment at all levels of the organization, in particular Quality, Quality Control, and Manufacturing Operations.
Work within all Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.

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.
Self-driven and capable of prioritizing.
Expanding understanding of network, databases, servers, and PCs.
Understanding of usage and administration of Waters NuGenesis.
Familiarity with Empower and one or more LIMS, LES/ELN and Document Management Systems.
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.
Ability to sense, understand, and react to others emotions and recognize the impact of their emotions on your and other's performance and behaviors.

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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