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Manufacturing Senior Associate

Thousand Oaks, CA
Top 3 Must Have Skill Sets:
    
1. Must have experience using Visio
2. Pharmaceutical manufacturing experience
3. Engineering degree

Description:

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. SENIOR MANUFACTURING ASSOCIATE Live What you will do Let’s do this. Let’s change the world. In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, improvement project implementation, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production.
Responsibilities include:
Support single use systems within manufacturing including issue resolution and design changes
● Write validation protocols and reports in support of cleaning validation, equipment commissioning, qualification, and change management.
● Demonstrate strategic problem solving skills and champion continual improvement
● Lead sophisticated projects using project management skills
● Apply sophisticated process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the detailed delivery of new technologies into the plant.
● Handle Quality Records, such as CCMS, CAPA, and deviations.
● Draft and revise GMP manufacturing documents (SOPs, Forms)
● Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute validation 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.
Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma
manufacturing professional we seek is a collaborative team-player with these qualifications.

Preferred Qualifications
• Degree in Engineering or Life Sciences
• Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development
• 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 coach, mentor and/or cross train colleagues within core technical area
• Ability to drive results through leadership of cross-functional teams
• Experience leading and managing projects
• Equipment and Cleaning Validation experience
• Understanding of single-use technologies
• Data analysis and/or data visualization skills

Basic Qualifications
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
Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates’
professional and personal growth and well-being.
• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

"This posting is for Contingent Worker, not an FTE"
 

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