Job Overview
Orion Project Services and our largest US client are teaming up for an exciting contract opportunity in Irvine, CA!!! Our client is in immediate need of a Process Operator, with prior experience Working with Biological samples in a production environment. If you have Laboratory experience working with Biologics in a Manufacturing environment, don't wait! We invite those who are eager to apply for this exciting opportunity today!
Job Description
The Process Operator performs functions associated with cGMP biologics manufacturing operations within the production facility. Including equipment set-up and batch processing. And works with Cell cultures operating Column chromatography, filtration, and Sampling. The Process Operator Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. This role works with Quality, Maintenance, Warehouse, Documentation and Materials Management departments to execute the production plan.
1 year initial contract
$27-$30/hr based on benefits.
8am-4pm Monday-Friday. Some Overtime Required.
Responsibilities
- Cell culture (from vial thaw to production scale).
- Column chromatography.
- Tangential flow filtration
- Sampling of in process and raw materials.
- Running glass washer / autoclave.
- Buffer / media preparation.
- Equipment preparation (CIP / SIP).
- Maintaining inventory levels.
- Operate and monitor production equipment to ensure optimal performance.
- Conduct routine inspections and maintenance on machinery to prevent downtime.
- Follow standard operating procedures (SOPs) and Good Manufacturing Practices (CGMP) to maintain compliance.
- Collaborate with team members to troubleshoot issues and implement solutions effectively.
- Handle materials safely, including receiving, storing, and packaging products as needed.
- Document production data accurately for reporting purposes.
- Assist in the fabrication of components as required by production schedules.
Experience
- Bachelor’s Degree or equivalent required.
- At least 2-5 years relevant experience working with Biological Production with good writing skills and computer skills.
- Working knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
- Working knowledge of safety, quality systems, and cGMPs is required
- Familiarity with laboratory processes and materials handling is a must.
- Previous experience in a manufacturing or warehouse environment is preferred.
- Experience operating forklifts or other material handling equipment is beneficial.
- A strong commitment to safety practices and quality control measures is essential.
Job Type: Contract
Pay: $27.00 - $30.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- Have you worked in a BSL level 3 environment before?
Experience:
- GLP: 2 years (Required)
- CGMP: 2 years (Preferred)
- Cell culture: 2 years (Required)
- Chromatography: 1 year (Required)
Ability to Commute:
- Irvine, CA 92612 (Required)
Ability to Relocate:
- Irvine, CA 92612: Relocate before starting work (Required)
Work Location: In person
