Biotech Manufacturing Specialist - Upstream/Downstream

Us Tech Solutions; Thousand Oaks (CA); On-site; USD 45,000 - 51,000; Full time

Job summary

US Tech Solutions in Thousand Oaks, CA seeks a Manufacturing Specialist with GMP drug substance experience to support Upstream/Downstream processes as Process Owner. This 14-month contract role requires on-site work Monday–Friday with occasional off-hours for implementation needs.

Ideal candidates have 3+ years in GMP environments, strong project management skills, and the ability to draft GMP documents, SOPs, and change control materials while adapting to changing priorities and maintaining

Qualifications

• Degree in Engineering or Life Sciences.
• 3+ years in Drug Substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
• Proficiency with GMP documents and writing protocols/reports.
• Proficiency with Smartsheet and Excel; TrackWise, Visio, SAP, Spotfire.

Responsibilities

• Provide subject-matter expertise for Drug Substance Upstream and Downstream processes as Process Owner (PPO).
• Lead cross-functional and complex projects using project management skills.
• Resolve quick issues and lead troubleshooting, including function testing to optimize process.
• Write GMP docs and reports in support of validation, testing, commissioning and change management.
• Own Quality Records such as CCMS, CAPA, and CAPA-EV.
• Apply technical knowledge with analytical troubleshooting to implement new technologies in the plant.

Skills

Go getter attitude

Adapt to changing priorities

Manufacturing experience

Data analysis

Data visualization

Education

Degree in Engineering or Life Sciences

Tools

Smartsheet

Excel

Trackwise

Visio

SAP

Spotfire

Job description

US Tech Solutions in Thousand Oaks, CA seeks a Manufacturing Specialist with GMP drug substance experience to support Upstream/Downstream processes as Process Owner. This 14-month contract role requires on-site work Monday–Friday with occasional off-hours for implementation needs.

Ideal candidates have 3+ years in GMP environments, strong project management skills, and the ability to draft GMP documents, SOPs, and change control materials while adapting to changing priorities and maintaining