Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant
About The Position
Bristol Myers Squibb is seeking a Senior Engineer, IT Laboratory & Quality Systems for their Devens Biologics Digital Plant. This role involves ensuring the secure administration of documentation and processes for benchtop equipment, lab, and quality systems. The position requires end-to-end management within BMS systems for changes, incidents, problems, and asset management, ensuring timely completion. The engineer will also conduct system reliability assessments, act as a plant subject matter expert (SME), and ensure application configurations, data integrity, and cybersecurity meet regulatory compliance. Additionally, the role involves assessing existing technologies for efficiency opportunities, collaborating with teams to develop methodologies, maintaining alignment with BMS directives and industry guidelines on validation, and supporting Quality and Manufacturing areas during audits and inspections. Telecommuting is permitted on a hybrid schedule, and up to 20% domestic travel is required.
Requirements
- 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 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.
- Five (5) years of experience utilizing Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), and Document Management Systems to support benchtop equipment.
- Five (5) years of experience administrating Waters NuGenesis and Empower to streamline workflows.
- Five (5) years of experience complying with standard operating procedures (SOPs) and pharmaceutical regulations including Good Documentation Practices (GDocP), Current Good Manufacturing Practices (cGMP), FDA and EU regulations.
- Five (5) years of experience leveraging knowledge in IT, network concepts, LDAP and Active Directory concepts, databases, servers, user account management, and operating systems.
- Five (5) years of experience supporting regulatory audits by researching responses to auditor questions and generating information/presentations to fulfil the auditor requirements.
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.
Benefits
- Annual discretionary bonus
- Healthcare: 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.
- Work-life benefits: Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
