Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant

About the role

Bristol Myers Squibb is seeking a Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant. This role offers unique opportunities for growth and development within a dynamic and innovative organization.

Responsibilities

• Ensure secure administration of documentation, processes of benchtop equipment, lab, and quality systems.
• Provide end-to-end management within BMS systems to support changes, incidents, problems, and asset management and ensure completion within defined timeframes.
• Conduct assessment of system reliability.
• Act as plant subject matter expertise (SME).
• Ensure application configurations, data integrity, and cyber security meet regulatory compliance.
• Assess existing technologies and identify opportunities for efficiencies.
• Collaborate with teams to develop methodologies.
• Maintain alignment with BMS directives and industry guidelines on validation.
• Support Quality and Manufacturing areas during audits and inspections from internal and external organizations.

Requirements

• A Bachelor's degree or foreign equivalent in Mechanical Engineering, Computer Engineering, or a related field, and five (5) years of progressive post-baccalaureate work experience as a Validation Engineer or in a related occupation.
• Five (5) years of experience with/in the following:
• Applying Lean methodologies and Operational Excellence (OpEx) principles to optimize the Software Development Life Cycle (SDLC) in a regulated industry such as Biotechnology or Pharmaceutical;
• Utilizing Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), and Document Management Systems to support benchtop equipment;
• Administering Waters NuGenesis and Empower to streamline workflows;
• Complying with standard operating procedures (SOPs) and pharmaceutical regulations including Good Documentation Practices (GDocP), Current Good Manufacturing Practices (cGMP), FDA and EU regulations;
• Leveraging knowledge in IT, network concepts, LDAP and Active Directory concepts, databases, servers, user account management, and operating systems;
• Supporting regulatory audits by researching responses to auditor questions and generating information/presentations to fulfill the auditor requirements.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Pay and Schedule

• $126,859.00 - $133,630.00
• Telecommuting permitted on a hybrid schedule as determined by the employer. Up to 20% domestic travel required.