GMP IT Systems Specialist – Lab & Manufacturing

RoslinCT; Hopkinton (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Educational assistance

401(k) program

Job summary

RoslinCT in Hopkinton, MA seeks an IT Scientific Systems Specialist to deliver technology services to GMP laboratories and manufacturing. You will collaborate with vendors and internal teams, manage equipment lifecycles, and develop validation protocols to ensure compliant operations.

Bachelor's in IT/CS/Engineering and strong problem-solving, communication, and documentation skills are required; optional experience with MES/LIMS systems and regulated environments is a plus.

Qualifications

• BS in Information Technology, Computer Science, Engineering or related technical discipline.
• Experience with benchtop equipment and instrumentation; MES and LIMS preferred.
• Experience in a regulated environment (21 CFR Part 11, GAMP preferred).
• Experience working in cross-functional, collaborative teams.

Responsibilities

• Develop and update equipment specifications and procedures.
• Coordinate with Vendors to establish requirements and lifecycle deliverables.
• Execute validation protocols as required.
• Assist onboarding, setup, and administration of equipment throughout its lifecycle.
• Participate in cross-functional teams to achieve project goals.
• Manage project deliverables respecting scope, budget and timeline.
• Create test plans, protocols, and CGMP documentation.

Skills

Analytical thinking

Problem-solving

Time management

Written and verbal communication

Microsoft Office

Diagnostic tools

Education

Bachelor's degree in Information Technology / Computer Science / Engineering

Tools

MES

LIMS

Job description

RoslinCT in Hopkinton, MA seeks an IT Scientific Systems Specialist to deliver technology services to GMP laboratories and manufacturing. You will collaborate with vendors and internal teams, manage equipment lifecycles, and develop validation protocols to ensure compliant operations.

Bachelor's in IT/CS/Engineering and strong problem-solving, communication, and documentation skills are required; optional experience with MES/LIMS systems and regulated environments is a plus.