Manufacturing Engineer

4 days ago

Menlo Park, California, United States Entegee Full time
Job Summary

Lead and coordinate manufacturing activities for pharmaceutical product development, including new product and process development, equipment validation, and quality systems management.

Key Responsibilities:

  • Participate in and contribute to the new product development of pharmaceutical drug products in alignment with the company's strategic plan.
  • Lead manufacturing engineering activities related to planning and executing builds and experiments for product development, process integration, and equipment qualification.
  • Support the development of the Pharmaceutical Quality System from a manufacturing engineering perspective.
  • Coordinate and manage manufacturing activities for product development batches, including engineering, qualification, and clinical builds.
  • Own and execute equipment qualification, maintenance, and calibration activities.
  • Collaborate with supply chain management for materials issuance for development and clinical builds.
  • Support cleanroom and cleaning qualification activities.
  • Own and support Master Validation Plans to ensure alignment between operations and the core team for sustainable commercial manufacturing.
  • Provide indirect management for assemblers and technicians conducting manufacturing operations.
  • Design manufacturing processes, procedures, and production layouts to ensure efficiency and productivity.
  • Inspect machinery, equipment, and tools for performance, initiating corrective actions as needed to ensure product quality.

Requirements:

  • Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or Mechanical Engineering.
  • 5+ years of experience in pharmaceutical product manufacturing and pharmaceutical quality systems.
  • Experience with new product and process development, including equipment and process validations.
  • Experience coordinating and leading manufacturing builds.

Preferred Skills:

  • Experience with biodegradable polymers and drug/device combination products.
  • Proficiency in drug coating processing, such as spray coating and dip coating.
  • Strong organizational and operational skills with attention to detail and the ability to manage multiple projects simultaneously.

Benefits:

  • Medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and 401K plan.
  • Available paid leave may include Paid Sick Leave, where required by law, and Holiday pay upon meeting eligibility criteria.

Pay Details: $55.00 to $65.00 per hour

Equal Opportunity Employer/Veterans/Disabled

Company Description: Entegee specializes in custom automation projects and is a major player in the world of controls and robotic solutions around the world.

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