Senior Lab Systems Engineer - GxP/CSV & Lab IT

TechDigital Group; Cambridge (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

TechDigital Group in Cambridge, MA is seeking a Sr Lab System Support Engineer to ensure lab systems operate smoothly. This entry-level position targets candidates with backgrounds in life sciences or IT and offers a dynamic role in a regulated pharmaceutical environment.

Applicants should have a Bachelor’s degree and at least 8 years of directly relevant experience. Responsibilities include managing lab systems and vendor communications, ensuring compliance with GLP and GMP standards, and supporting QA and IT teams in troubleshooting.

Qualifications

• 8+ years of experience in laboratory or IT support role.
• Ability to work in a regulated environment and follow SOPs.
• Good knowledge of the Problem/Deviation/Change/CAPA Management Process.

Responsibilities

• Manage end to end lab system lifecycle including implementation, validation, maintenance, and decommissioning.
• Ensure compliance with SDLC CSV GxP and regulatory standards.
• Coordinate maintenance upgrades and ensure SLA and regulatory compliance.
• Support compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA regulations.

Skills

Knowledge of GXP

Computer System Validation

Laboratory instruments knowledge

Communication skills

Problem-solving

Familiarity with lab software systems

Knowledge of Ticketing systems

Understanding of Problem/Deviation/Change/CAPA Management

Education

Bachelor's degree in Life Sciences, Chemistry, Biology, Computer Science

Job description

TechDigital Group in Cambridge, MA is seeking a Sr Lab System Support Engineer to ensure lab systems operate smoothly. This entry-level position targets candidates with backgrounds in life sciences or IT and offers a dynamic role in a regulated pharmaceutical environment.

Applicants should have a Bachelor’s degree and at least 8 years of directly relevant experience. Responsibilities include managing lab systems and vendor communications, ensuring compliance with GLP and GMP standards, and supporting QA and IT teams in troubleshooting.