Lab Ops Support Engineer
Foster City, CA (onsite 5 days a week)
Long Term Rolling Contract
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.
Additional responsibilities for the role on site:
- 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.
Qualifications:
- 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
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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