Biotech Upstream Manufacturing Specialist (Contract)

Us Tech Solutions; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

US Tech Solutions seeks a Manufacturing Specialist to support Drug Substance upstream and downstream processes as a Process Owner (PPO). The role requires at least 1 year of biotech/pharma manufacturing experience and an ability to lead cross-functional projects, troubleshoot, and compile validation and change-management documents.

Onsite work in Thousand Oaks, CA, with occasional non-standard hours based on implementation needs.

Qualifications

• 1+ year of biotech/pharma manufacturing experience, upstream preferred.
• Onsite work Monday–Friday with occasional non-standard hours for implementation needs.
• Familiarity with project management and related tools is desirable.

Responsibilities

• Provide SME support for Drug Substance Upstream and Downstream as Process Owner (PPO).
• Lead cross-functional projects using PM skills.
• Troubleshoot and execute function tests to optimize processes.
• Draft protocols and reports for validation, testing, commissioning, and change management.
• Own Quality Records (CCMS, CAPA, CAPA-EV).
• Support implementation of new technologies with technical, operational, and compliance knowledge.

Skills

Go getter attitude

Adaptability

Manufacturing experience

Data analysis

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Smartsheet

Excel

Trackwise

Visio

SAP

Spotfire

Job description

US Tech Solutions seeks a Manufacturing Specialist to support Drug Substance upstream and downstream processes as a Process Owner (PPO). The role requires at least 1 year of biotech/pharma manufacturing experience and an ability to lead cross-functional projects, troubleshoot, and compile validation and change-management documents.

Onsite work in Thousand Oaks, CA, with occasional non-standard hours based on implementation needs.