GMP IT Systems Engineer — Lab & Manufacturing

Oncology Voice Network LLC; Hopkinton (MA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Dental insurance

Health insurance

401(k) program

Job summary

RoslinCT in Hopkinton, MA is seeking an IT Scientific Systems Specialist to deliver daily technology services to GMP laboratories and manufacturing. You will develop equipment specifications, coordinate with vendors, and execute validation protocols to ensure compliant operations.

You will support onboarding of equipment, participate in cross-functional teams, manage project deliverables within scope, budget, and timeline, and prepare CGMP documentation.

Qualifications

• BS in Information Technology, Computer Science, Engineering or related technical discipline.
• Experience with benchtop equipment and instrumentation, MES and LIMS preferred.
• Experience with systems including; extracting data, reporting, creating queries, security configuration, hardware configuration, interfacing with process equipment and laboratory instrumentation, and troubleshooting is preferred.
• Experience working in a regulated environment, 21 CFR Part 11, GAMP, etc. strongly preferred.

Responsibilities

• Develop and update equipment and instrument specifications and procedures.
• Coordinate with Vendors to manage installations, configuration, and lifecycle deliverables.
• Execute validation protocols as required.
• Support equipment onboarding, setup, and administration throughout the equipment lifecycle.
• Actively participate in cross-functional teams and collaborate across the organization to accomplish project and operational goals.
• Manage project deliverables to completion to ensure success as defined by adherence to standards of scope, budget, and timeline.
• Develop comprehensive plans and coordinate various with managers and technical personnel during all project phases, from initial development through implementation.
• Design, update, and prepare test plans, protocols, and reports.
• Execute comprehensive CGMP documentation to support project and operational deliverables
• Communicate proactively with all involved personnel to identify problems, create solutions, and implement efficiency improvements.

Skills

PC hardware

Networking

Analytical thinking

Time management

Communication skills

Problem solving

Project management

MS Office

Education

BS in IT/CS/Engineering or related

Tools

Manufacturing Execution Systems

Laboratory Information Management Systems

Job description

RoslinCT in Hopkinton, MA is seeking an IT Scientific Systems Specialist to deliver daily technology services to GMP laboratories and manufacturing. You will develop equipment specifications, coordinate with vendors, and execute validation protocols to ensure compliant operations.

You will support onboarding of equipment, participate in cross-functional teams, manage project deliverables within scope, budget, and timeline, and prepare CGMP documentation.