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MCS Manufacturing Sr. Associate

Thousand Oaks, CA 91320

Posted: 07/17/2024 Employment Type: Contract Job Category: Manufacturing Job Number: 3894

Job Description

Responsibilities:
  • Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as Single-use SME
  • Lead sophisticated projects or parts of projects using project management skills.
  • Resolve quick issues and execute function tests to troubleshoot and optimize process
  • Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
  • 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 New Product introduction and projects through Single Use Systems (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
Basic Qualifications    
  • Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Preferred Qualifications:
  • Degree in Engineering or Life Sciences
  • 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.
  • Team player - Ability to support team by reprioritizing or readjusting projects, tasks, or responsibilities.
  • Ability to drive results through leadership of cross-functional teams
  • Experience leading and managing projects
  • Understanding of SUS technologies
  • Data analysis and/or data visualization skills
  • Excellent writing skills. Presentation experience – presentation to leadership or auditors.
  • Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively
  • Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, spotfire
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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.