This role provides site-wide support for clinical lab operations activities. Responsibilities will include the installation, maintenance, and sustained performance of cutting-
edge laboratory equipment along with documenting activities in accordance with regulatory compliance guidelines. Laboratory equipment supported will range widely, but will include next- generation sequencing platforms and automated liquid handling robots. This position will work in close collaboration with the clinical lab staff and cross functional teams and represent Engineering Operations as point of contact in cross-departmental technical meetings. Strong interpersonal,organizational, and troubleshooting skills are essential for success in this position.
location: Durham, North Carolina
job type: Contract
salary: $25 - 33 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Support routine and non-routine service provider visits, internal and cross-functional investigations, and software / firmware upgrades and assessments.
- Maintain equipment lifecycle records in our Asset Management System for traceability and perform all work in compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements, and the Company QMS (Quality Management System).
- Perform on-site troubleshooting, recovery, debugging, repairs, and routine and non-routine maintenance of laboratory equipment, hardware, and systems.
- Revise, update, and execute, test plans, IOPQ protocols, site acceptance testing (SAT), verifications, and standard operating procedures (SOPs) as needed.
- Respond to the Engineering Operations support ticketing system in a timely manner, escalating where appropriate.
- Respond to environmental monitoring system alert notifications for cold storage units and laboratory temperature/humidity sensors in a timely manner, escalating where appropriate.
- Provide technical training and transfer knowledge to fellow engineers/technicians and clinical laboratory operators.
- Participate and adhere to Company's policies and guidelines.
- Recommend and implement changes to ensure ongoing high-quality performance of laboratory equipment as part of the continuous improvement process.
- Support identification of and solutions to the root cause of software and hardware discrepancies, deviations and non-conformances.
qualifications:
Required:
- BS/BA or equivalent in Engineering (Mechanical, Chemical or Electrical)
- Experience handling clinical lab equipment like liquid handlers, thermocyclers, washers, shakers or incubators
- GMP and GDP knowledge
- Experience working on Computerized Maintenance Management Systems (CMMS)
- Hands on documentation of service reports: root cause analysis, recording of corrective preventative actions (CAPA) and outcomes, verifying return to service status and closing work orders
skills: GMP (Good Manufacturing Practice), Mechanical Engineering
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
