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Manufacturing Sr. Associate

3 months ago

Thousand Oaks, United States The Steely Group Full time

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