Manufacturing Process Technician

Thousand Oaks, California
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -112019-50258

Job Summary:

  • Analytical testing, characterization, sample and data management
  • Equipment maintenance
  • Contributes to team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of milestones associated with specific projects or activities within the team.
  • Support manual visual inspection of filled units


Specific Job Duties:

  • Plan and perform routine analyses with efficiency and accuracy.
  • Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
  • May perform aseptic aliquoting, sampling and analysis of compendia methods
  • Prepare complete and accurate laboratory documentation following GMP guidelines.
  • With a high degree of technical flexibility, work across diverse areas within the lab.
  • Evaluate analytical data
  • Perform general lab housekeeping
  • Maintain/operate specialized equipment
  • Comply with safety guidelines, GMPs and other applicable regulatory requirements
  • Initiate and/or implement changes in controlled documents
  • Troubleshoot, solve problems and communicate with stakeholders
  • Participate in audits, initiatives, and projects that may de departmental or organizational in scope
  • Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
  • May participate in lab/inspection investigations
  • May provide technical guidance
  • May train others
  • May contribute to regulatory filings
  • May represent the department/organization on various teams
  • May interact with outside resources
  • Support manual visual inspection of drug product filled units
  • Deepens technical knowledge trough exposure and continuous learning


Basic Education:

  • Bachelor’s Degree in Life Sciences & minimum 2 years of biopharma industry QC experience or related quality control or GMP laboratory experience
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products


Skills:

  • Filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system; basic GMP knowledge
  • Experience in GMP facility; Ability to perform tasks following standard operating procedures, protocols, and/or test plans comfort with electronic control systems (Delta V, MES)
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