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Downstream Manufacturing Technical Specialist
Job in
Tustin, Orange County, California, 92681, USA
Listed on 2026-09-23
Listing for:
BioTalent
Full Time
position Listed on 2026-09-23
Job specializations:
-
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Manufacturing Engineer, Quality Engineering -
Engineering
Validation Engineer, Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Downstream Manufacturing Technical Specialist
Support the Manufacturing of Life-Saving Biopharmaceuticals
Ideal opportunity for downstream bioprocessing professionals with technical manufacturing expertise and commercial GMP experience.
Are you passionate about downstream manufacturing, process transfer, and technical operations
? We're looking for a Downstream Manufacturing Technical Specialist to support manufacturing readiness, process execution, equipment oversight, and cross-functional collaboration within a commercial biologics manufacturing environment.
- Support the successful transfer and execution of downstream manufacturing processes
- Serve as a key technical liaison between Manufacturing, MSAT, QA, Facilities, and other cross-functional teams
- Support review and approval of batch production records, manufacturing documentation, and technical reports
- Collaborate on process improvements to enhance performance, efficiency, robustness, compliance, and safety
- Manage downstream equipment readiness, utilization, calibration schedules, and manufacturing support needs
- Lead technical and on-the-job training activities for downstream manufacturing personnel
- Support technical investigations, CAPAs, and manufacturing issue resolution activities
- Communicate manufacturing process status and provide technical support for production operations
- B.S. or M.S. in a scientific or engineering discipline (Chemical Engineering, Biomedical Engineering, or related field)
- 4+ years of downstream manufacturing experience with a B.S. degree or 2+ years with an M.S. degree
- Strong technical experience in commercial cGMP manufacturing environments
- Technical expertise in downstream processing operations and equipment
- Experience supporting purification and bioprocessing activities including chromatography, filtration, viral clearance, and bulk drug substance manufacturing
Hourly Rate: $25.48 - $34.00 per hour
Additional compensation and benefits package available
Please Note- On-site in Tustin, CA
- Schedule is Monday through Friday, 8:00 AM to 5:00 PM
- Overtime, weekend, and holiday support may be required based on business needs
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