Job Title: Lab Quality Systems Engineer
Location: Devens, MA 01434 (100% onsite)
Job ID 82266
Requirements:
- Perform analytical instrument computer system qualification in accordance with Client procedures and under Client supervision and guidance.
- Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support includes various instrument types such as ViCell, SoloVPE, Cary60, and Spectramax plate readers across laboratory and manufacturing buildings.
- Lead or support activities within the quality management system (Infinity).
- Liaise with global partners within the Client organization to align on solutions and implementation plans for benchtop instrumentation, performing system installations, configurations, administrative and support functions including system qualification lifecycles and training.
- Provide ownership of assets and utilize Client systems to support changes, incidents, problems, and asset management activities for benchtop equipment and lab and quality systems within ServiceNow.
- Execute and update documentation to support benchtop equipment and lab/quality systems ensuring assets are reliable, accessible, and secure.
- Ensure alignment with Client directives and industry guidelines for applications.
- Execute multiple projects and technical work assignments as a point of contact for project stakeholders.
- Provide local administrative support and liaise with partners for site quality systems and quality control applications, completing tasks such as application periodic reviews, user access reviews, and account administration.
- Provide digital plant subject matter expertise (SME) to cross-functional teams, advising operations on application configurations, data integrity, and cybersecurity.
- Execute on technology improvements and efficiency opportunities to improve business operations and compliance.
- Knowledge of requirements for design, installation, commissioning, and qualification of computerized systems and equipment using risk-based approaches.
- Experience using electronic systems for qualification testing (e.g., ALM, ValGenesis, etc.).
- Service Provider shall comply with, perform services, and manage data under current ICH GxP guidelines, FDA rules, and Client procedures.
- Generate project, lifecycle, and/or compliance deliverables related to the services described for all assigned projects and tasks, in accordance with dates agreed upon with the Client supervisor.
Skill/Knowledge Requirements:
- BS degree in life sciences, engineering, or computer science field, or equivalent experience
- Minimum 5+ years of experience working in regulated industries such as biotech, pharmaceutical, or medical devices, with familiarity supporting benchtop instruments and applications within a GxP-compliant manufacturing or laboratory setting
- Strong understanding of SOPs, cGMPs, Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices
- Understanding of networks, databases, servers, and PCs
- Strong application administration capabilities and a willingness to embrace emerging technologies
- Experience or knowledge of working in a regulated environment, including application administration (configuration, updates, backend work)
- Experience with computer/server administration (equipment repairs, server configurations, folder permissions, Windows 7/10/11 administration knowledge)
Location and Conditions:
- This role is 100% onsite 40 hours/week
- Work schedule: Monday - Friday, Business Hours
- Candidate is required to be onsite and will need to gown into manufacturing environment on a weekly basis