Senior Associate - Manufacturing Technical Operations Production Process Owner

Senior Associate - Manufacturing Technical Operations (MTO) Production Process Owner (PPO)

Location: Thousand Oaks, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 4 months
• Pay Rate: $23.00 $28.00 / Hour (USD)
• Shift / Schedule: Days (1st Shift)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

In this vital role, you will be part of the Manufacturing Technical Operations (MTO) Production Process Owner (PPO) team, which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single-use technologies. The position is within the drug product supply organization in ATO Building 20, which is a dynamic environment and an important launch point for the client's pipeline products. The plant manufactures drug products at all phases of clinical trials through commercial production.

Key Responsibilities

• Support manufacturing by providing subject-matter expertise for drug product vial and syringe filling processes as production process owner (PPO)
• Lead sophisticated projects or parts of projects using project management skills.
• Resolve quick issues and execute function tests to troubleshoot and optimize processes
• 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.
• 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.
• 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.
• Ability to be on-site (flexible worker)
• 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 product manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
• Support New Product introduction and projects through SUS mapping
• Support manufacturing and quality through the SUS defect/leak triage process perform troubleshooting on the floor, initiate investigation, and bring leaks and defects to triage
• Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
• Understand single-use material capabilities and user requirements for new technologies.

Required Skills

• Project Management
• Communication Skills
• Willingness to Learn

Education Requirements

• Master's degree OR Bachelor's degree and 2 years of manufacturing and operations experience OR Associate's degree and 4 years of manufacturing and operations experience OR High school diploma/GED and 6 years of manufacturing and operations experience

Required Experience

• Minimum 2 years of manufacturing and operations experience (with Bachelor's degree); or 4 years with Associate's degree; or 6 years with High school diploma/GED

Work Environment / Physical Requirements

• Must be able to work in a clean room environment wearing steel-toe shoes, full clean room gowning, hairnet, and gloves
• Must follow GMP documents (SOPs) with strict adherence to safety and compliance
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule
• Must be able to commute to Thousand Oaks site daily

Important Notes

• Interview Process: Manager Screening followed by Team Panel Interview

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-10539 Industry: Manufacturing & Operations

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