Demo

Validation Engineer

Shoolin Inc
Santa Rosa, CA Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 6/7/2025

Job : Validation Engineer

Location : Bay Area, CA (Onsite)

Duration : 12 months

Responsibilities :

  • Develop and manage test protocols and validation reports for equipment.
  • Oversee equipment / process qualifications, including automation lines and lyophilizers (freeze-dryers).
  • Work with suppliers to create and approve validation reports.
  • Perform periodic reviews of equipment to keep them validated.
  • Manage Engineering Change Control.
  • Create project timelines with risk mitigation plans.
  • Collaborate with Quality teams to improve maintenance and calibration processes.
  • Use tools like MiniTab for statistical analysis.
  • Troubleshoot issues and provide corrective actions.
  • Support teams to improve operations.

Requirements :

  • Bachelor’s degree in Mechanical, Electrical, Chemistry, Biology, or Physics.
  • 7 years of experience in manufacturing.
  • Experience with Fill / Pack and Lyophilizer (Freeze-Dryer) validation.
  • Strong problem-solving skills.
  • Ability to work with different teams and handle changing priorities.
  • Familiarity with ERP systems and change control.
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