Validation Equipment Engineer

job
  • ACL Digital
Job Summary
Location
Thousand Oaks ,CA 91362
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
03 Jan 2025
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Job Description

Job Title: Senior Engineer/Analytical

Location: Thousand Oaks CA

Duration: 12 Months


Description:

100% Onsite - Regular hours

Ideal Candidate: 5+ YOE and B.S. top 3 skillsets are a must have!


The Sr. Engineer, Analytical will lead the troubleshooting, vendor support, commissioning,

qualification, validation, decommissioning, and project work associated with a wide variety of analytical equipment that supports manufacturing.


Top 3 Must Have Skill Sets:

Analytical Equipment Troubleshooting

Commissioning, Qualification, and Validation of Analytical Equipment

Manufacturing Support


Scope includes a wide range of devices such as Cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers. The qualified candidate will work with the analytical team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.


Responsibilities: - Work cross-functionally with individuals and project teams in Analytical, Engineering, Instrumentation, and Manufacturing. Determine technical coverage and proper integration different subsystems. Create and execute to project plans and schedules. Develop, execute, and review documents, qualification and validation plans and other related development documents for assigned projects. Provide deep technical assistance for other support staff and operators using equipment. Support of different equipment in multiple buildings within the Amgen Thousand Oaks campus


Skills: BS in Engineering, Biotech, or Equivalent and previous experience in a biotech/pharmaceutical industry with focus on analytical equipment - 5 years current experience with analytical processes and procedures. - Led projects from development through commissioning, qualification, validation, and/or decommissioning. Strong background in troubleshooting, root cause analysis, and vendor coordination. Must be capable of working on multiple projects in a deadline driven environment.

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

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