Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:

• Laboratory Quality Systems Engineer

Location:
Devens, MA (100% Onsite)

Schedule:
Monday–Friday, regular business hours.
Note: Candidate must be able to gown into a manufacturing environment on a weekly basis.

Description of Services:
Validation & Engineering Group is seeking to provide a qualified resource to support project execution and ongoing maintenance of laboratory quality systems and benchtop instrumentation at a regulated manufacturing site. The selected engineer will be responsible for the following services:

• Perform analytical instrument computer system qualification following internal procedures and under client direction.

• Administer and support benchtop instrumentation applications, PC hardware, and IT administrative tools in a GxP setting.

• Provide technical support for instruments such as ViCell, SoloVPE, Cary60, and Spectramax plate readers across laboratory and manufacturing areas.

• Lead or support activities within the local quality management system.

• Collaborate with global stakeholders to align solutions and implement plans for benchtop systems, including installations, configurations, qualifications, and training.

• Maintain and manage asset data, incidents, problems, and changes using systems such as ServiceNow.

• Generate and update documentation to ensure reliability, accessibility, and security of supported systems.

• Ensure compliance with internal directives and industry standards.

• Execute projects and technical assignments, serving as point of contact for stakeholders.

• Provide local administrative support for quality systems, including periodic reviews, user access reviews, and account administration.

• Act as a subject matter expert in digital plant systems, advising on configurations, data integrity, and cybersecurity.

• Identify and implement technology and process improvements to enhance compliance and efficiency.

• Create project and compliance deliverables aligned with agreed timelines and requirements.

Required Skills and Qualifications:

• Bachelor’s degree in life sciences, engineering, computer science, or equivalent experience.

• 5+ years of experience in a regulated industry (biotech, pharma, medical devices) supporting benchtop instrumentation and lab systems.

• In-depth knowledge of GxP, cGMP, SOPs, Data Integrity, SDLC, and Good Documentation Practices.

• Application administration experience, including configuration, upgrades, and backend support.

• Computer/server administration experience (hardware repair, folder permissions, Windows 7/10/11).

• Familiarity with electronic qualification systems (e.g., ALM, ValGenesis).

• Understanding of risk-based qualification methodologies for computerized systems.

• Strong technical and interpersonal communication skills.