Specialist Manufacturing #26-24775

US Tech Solutions•Thousand Oaks, CA

1d•Hybrid

About The Position

The ideal candidate for the Manufacturing Specialist role will have at least 1 year of relevant experience in a biotech or pharmaceutical manufacturing environment, with a strong preference for those with upstream operations experience. This position supports manufacturing from a process owner’s perspective, so candidates should be comfortable working onsite Monday through Friday, with occasional flexibility for non-standard hours (including weekends) based on implementation needs. While some remote administrative work (e.g., SOP revisions, tracker updates) may be allowed, onsite support is expected. Candidates should demonstrate a go-getter attitude, strong adaptability to changing priorities, and a willingness to ask questions and escalate when unsure. Familiarity with project management, as well as tools like Smartsheet and Excel, is highly desirable but not required. Responsibilities include: Support manufacturing by providing subject-matter expertise for Drug Substance Upstream and Downstream processes as Process Owner (PPO). Lead cross-function and complex projects using project management skills. Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process. Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management. Own Quality Records, such as CCMS, CAPA, and CAPA-EV. Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant. Demonstrate strategic problem-solving skills and champion continual improvement. Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations. Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance. As Process owner: Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.

Requirements

At least 1 year of relevant experience in a biotech or pharmaceutical manufacturing environment.
Strong preference for those with upstream operations experience.
Comfortable working onsite Monday through Friday, with occasional flexibility for non-standard hours (including weekends) based on implementation needs.
Demonstrate a go-getter attitude.
Strong adaptability to changing priorities.
Willingness to ask questions and escalate when unsure.
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.

Nice To Haves

Familiarity with project management.
Familiarity with tools like Smartsheet and Excel.
Degree in Engineering or Life Sciences
3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to navigate through ambiguity and identify and deliver on key milestones.
Ability to advise and influence using experience and data.
Data analysis and/or data visualization skills
Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, spotfire

Responsibilities

Support manufacturing by providing subject-matter expertise for Drug Substance Upstream and Downstream processes as Process Owner (PPO).
Lead cross-function and complex projects using project management skills.
Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process.
Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
Own Quality Records, such as CCMS, CAPA, and CAPA-EV.
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
Demonstrate strategic problem-solving skills and champion continual improvement.
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
Develop/own drug substance manufacturing processes and procedures.
Draft and revise GMP manufacturing documents (SOPs, Forms).
Draft and develop user requirements for new technologies.