Manufacturing Process Engineer

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Specific Responsibilities

The successful candidate will:

  • Develop and execute documentation to support new client projects, including bill of materials, manufacturing routers, material specifications, and batch records/work instructions
  • Review and support the transfer of client instructions for formulation/filling of their product and suggest improvements, where possible
  • Identify challenges and solutions related to scale up from development to production activities
  • Support designing, specifying and validating equipment and processes
  • Ability to transfer equipment and process from clients to Argonaut manufacturing
  • Facilitate transition of new methodologies into manufacturing laboratory
  • Respond to process and instrument failures to minimize downtime
  • Improve formulation processes and procedures
  • Author and support quality events which could include deviations, non-conformances and client complaints

Position Requirements and Experience

  • Bachelor’s degree in Biology, Chemistry or Engineering, with 3-4 years of industry experience in life science, biotechnology and/or contract manufacturing
  • Understanding of basic chemistry and microbiology (molarity, molality, pH, sterility, etc.)
  • Understanding of how to make dilutions and formulations from stock solutions
  • Knowledge of ISO 13485 Quality Management System and GMP
  • Must be meticulous and organized with excellent problem solving and analytical skills
  • Effective interpersonal and communication skills
  • Intermediate to expert user knowledge of Microsoft Word
  • Self-starter who can independently drive projects and day-to-day work tasks to completion while staying on schedule
  • Must work cross functionally with team
  • An understanding of LEAN practices and the use of continuous improvement tools like Kaizen, 5 why’s, fishbone diagrams, DMAIC, poka yoke, value stream mapping
  • Use of Microsoft Projects or Gantt charts in general
  • Understanding of FMEA and risk management
  • Experience with Master Control
  • Intermediate to expert user knowledge of Microsoft Excel
  • Interest or ability to program equipment

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

Apply for this Job

Fill out the form below. When selecting “jobs/career”, a section to upload your CV/Resume will appear.