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

Duties:
- Ensure secure administration of documentation and benchtop equipment, lab, and quality systems.
- Provide end-to-end management in BMS systems for changes, incidents, problems, and asset management within defined timeframes.
- Assess system reliability; act as plant subject matter expert (SME).
- Ensure application configurations, data integrity, and cybersecurity meet regulatory compliance.
- Assess existing technologies; identify efficiency opportunities and collaborate on methodologies.
- Maintain alignment with BMS directives and industry validation guidelines.
- Support Quality and Manufacturing during internal/external audits and inspections.
- Hybrid telecommuting permitted as determined by the employer; up to 20% domestic travel.

Requirements:
- Bachelor’s degree (or foreign equivalent) in Mechanical Engineering, Computer Engineering, or related field, plus 5 years post-baccalaureate experience as a Validation Engineer (or related).
- 5 years’ experience with:
- Lean/Operational Excellence principles to optimize SDLC in regulated biotech/pharma.
- LIMS, LES, ELN, and document management systems for benchtop equipment.
- Waters NuGenesis and Empower administration.
- SOP and pharmaceutical compliance (GDocP, cGMP, FDA/EU regulations).
- IT/network concepts (LDAP, Active Directory), databases, servers, user account management, operating systems.
- Supporting regulatory audits by researching auditor questions and creating required information/presentations.

Benefits (as stated): annual discretionary bonus; healthcare, wellbeing, and 401(k)/insurance/disability benefits; paid time off.

Apply: Use req. number R1603228 online or email resume to resume.com@bms.com.