Senior Analytical Equipment Engineer – Troubleshooting, CQV & Manufacturing Support - (JP15745)

3 Key Consulting•Thousand Oaks, CA

1d•Onsite

About The Position

The Sr. Engineer, Analytical will lead the troubleshooting and vendor support for a wide variety of analytical equipment that supports manufacturing. 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.

Requirements

5+ YOE and B.S.
Analytical Equipment Troubleshooting
Commissioning, Qualification, and Validation of Analytical Equipment
Manufacturing Support experience
5 years current experience with analytical processes and GMP procedures.
Strong background in troubleshooting, root cause analysis, and vendor coordination.
Must be capable of working on multiple projects in a deadline driven environment.
BS in Engineering, Biotech, Chemistry, or Equivalent and previous experience in a biotech/pharmaceutical industry with focus on usage and/or analytical equipment of specified equipment.

Nice To Haves

Team lead mentality able to come into that role
Self-starter
Strong communication and ability to independently manage and drive tasks to completion

Responsibilities

Lead the troubleshooting and vendor support for a wide variety of analytical equipment that supports manufacturing.
Ensure uptime of equipment and improve reliability.
Coordinate troubleshooting activities with the team and vendor.
Manage preventative maintenance, spare parts, SOPs, and forms.
Drive continuous improvement activities.
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 to project plans and schedules.
Review qualification documents 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 client’s Thousand Oaks campus.
Hands on troubleshooting of multiple types of analytical equipment.
Coordination of vendor support.
Project support for commissioning, qualification, validation, and decommissioning.
Execution of preventative and corrective maintenance, user access audits, password management.
GMP document revisions, deviation support/ownership, continuous improvement implementation, and management of equipment in an audit ready state.