I.T. Solutions, Inc. · 1 day ago
Lab Ops Support Engineer
Foster City, CA
Full-time
Onsite
Senior Level
$45/hr - $50/hr
5+ years expI.T. Solutions, Inc. is seeking a Lab Ops Support Engineer to perform data integrity operations and maintenance tasks associated with GMP standalone systems. The role involves coordinating with cross-functional stakeholders, managing laboratory instrumentation, and ensuring compliance with regulatory requirements.
ConsultingInformation TechnologyOutsourcingProject ManagementSoftware
Responsibilities
Responsible for performing Data Integrity Ops and Maintenance tasks such as System Audit trail Review, Periodic Account Review, Review of Periodic data Restoration, and supporting other maintenance tasks associated with GMP standalone systems
Identify, document, report, and take part into the resolution of any important findings during the review
Provide support to system related project such as upgrade and enhancements
Ensure documentation and work orders for standalone systems and maintenance related activities are completed on time. Forms and other supporting documentation are archived in the GVault
Coordinate with cross-functional stakeholders such as IT, QA, Business Process Owners, Software vendor etc
Contribute to the support and maintenance of operational documentation including Work Instructions, needed for system audit trail reviewers
Provide maintenance/management of various laboratory instrumentation and equipment with occasional direction from senior staff
Maintenance includes installation
Management includes logistics, coordination & support of vendor engineers as well as technical review of service report
Document work in accordance with standard operating procedures and established maintenance schedules to meet regulatory requirements
Work with lab staff to schedule maintenance and train others on equipment/operations as needed while working onsite at the client lab facility
Perform and assist vendor related Qualifications activities on GMP and Research instrumentation and equipment
Reviews vendor documentation relating to installation and qualification activities
Oversees and manages installation of new laboratory instrumentation and equipment
Assist in service activities related to Vendor Services
Coordinates all vendor service scheduling, contract management and data related activities
Participates/coordinates multidisciplinary project teams to ensure projects progress smoothly. Attends team meetings to communicate progress of projects and issues to client management
Qualification
Required
Bachelor's degree or equivalent (Biotech, Engineering, life sciences)
5-6 years in a similar role within the Pharma industry
Solid knowledge in Instruments
Willing to learn CSV as well
Benefits
Comprehensive and highly competitive benefits package
Company
I.T. Solutions, Inc.
itsoli is a Consulting and Professional Services firm that provides the in-depth expertise your business needs and the flexibility your changing environment requires to help you succeed.
201-500 employees
H1B Sponsorship
I.T. Solutions, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (19)
2023 (19)
2022 (22)
2021 (8)
2020 (8)
Funding
Current Stage
Growth StageLeadership Team
Tina Khouri
Partner
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