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

About the role

Join us as a Senior Engineer, IT Laboratory & Quality Systems, Devens Biologics Digital Plant. Transform patient lives through science.

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

• Bachelor's degree or foreign equivalent in Mechanical Engineering, Computer Engineering, or a related field.
• Five (5) years of progressive post-baccalaureate work experience as a Validation Engineer or in a related occupation.
• Experience with 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.
• Experience with Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), and Document Management Systems to support benchtop equipment.
• Experience administering Waters NuGenesis and Empower to streamline workflows.
• Experience complying with standard operating procedures (SOPs) and pharmaceutical regulations including Good Documentation Practices (GDocP), Current Good Manufacturing Practices (cGMP), FDA and EU regulations.
• Leverage knowledge in IT, network concepts, LDAP and Active Directory concepts, databases, servers, user account management, and operating systems.
• Support regulatory audits by researching responses to auditor questions and generating information/presentations to fulfill the auditor requirements.

Qualifications

• Experience with IT, network concepts, LDAP and Active Directory concepts, databases, servers, user account management, and operating systems.
• Experience with laboratory information management systems (LIMS), laboratory execution systems (LES), electronic lab notebooks (ELN), and document management systems.
• Experience with Waters NuGenesis and Empower to streamline workflows.
• Experience with regulatory compliance, including Good Documentation Practices (GDocP), Current Good Manufacturing Practices (cGMP), FDA and EU regulations.
• Experience with regulatory audits and responding to auditor questions.

Skills

• Strong understanding of IT infrastructure and network concepts.
• Experience with laboratory information management systems (LIMS), laboratory execution systems (LES), electronic lab notebooks (ELN), and document management systems.
• Knowledge of regulatory compliance, including Good Documentation Practices (GDocP), Current Good Manufacturing Practices (cGMP), FDA and EU regulations.
• Ability to conduct assessments of system reliability and identify opportunities for efficiencies.
• Experience with regulatory audits and responding to auditor questions.

Benefits

• Healthcare coverage including 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 including a 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

$126,859.00 - $133,630.00

Schedule

Hybrid schedule with up to 20% domestic travel required.