Specialist Manufacturing #26-24775

Us Tech Solutions; Thousand Oaks (CA); Vor Ort; USD 45.000 - 51.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Go getter attitude

Adapt to changing priorities

Manufacturing experience

Data analysis

Data visualization

Ausbildung

Degree in Engineering or Life Sciences

Tools

Smartsheet

Excel

Trackwise

Visio

SAP

Spotfire

Jobbeschreibung

$33.42-$37.13 per hour

Thousand Oaks, CA

Contract

Duration: 14-months contract

Shift: Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs)

Job Description:

• 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 elevate 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. Preferred Qualifications:
• 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.
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Data analysis and/or data visualization skills
• Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, spotfire. Must Have Skill Sets:
• Go getter attitude
• Ability to adapt to changing priorities
• Manufacturing experience

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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