Sr. Engineer, Analytical

Location: 100% Onsite - Thousand Oaks, CA

Job Type: W2, Contract, 12 Months

Ideal Candidate:

• 5+ years of experience (YOE)
• Bachelor's degree (B.S.)

Top 3 Must-Haves:

• Analytical Equipment Troubleshooting
• Commissioning, Qualification, and Validation of Analytical Equipment
• Manufacturing Support

Job Description: 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.

Scope of Work:

• Manage a wide range of devices such as cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers.
• Ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor.
• Manage preventative maintenance, spare parts, SOPs, and forms.
• 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 of different subsystems.
• Create and execute 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 different equipment in multiple buildings within the company's Thousand Oaks campus.

Day-to-Day Activities:

• Hands-on troubleshooting of analytical equipment.
• Coordination of vendor support.
• Project support for commissioning, qualification, validation, and decommissioning.
• Execution of preventative maintenance, user access audits, and password management.
• Support of different equipment in multiple buildings within the company's Thousand Oaks campus.

Skills and Qualifications:

• Bachelor's degree in Engineering, Biotech, or equivalent.
• Previous experience in the biotech/pharmaceutical industry with a focus on analytical equipment.
• 5 years of current experience with analytical processes and procedures.
• Proven experience leading projects from development through commissioning, qualification, validation, and/or decommissioning.
• Strong background in troubleshooting, root cause analysis, and vendor coordination.
• Ability to work on multiple projects in a deadline-driven environment.