3key Consulting, Inc.
Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Overview
Job Title:
Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477)
Location:
Thousand Oaks, CA 91320
Business Unit:
Facilities and Equipment Drug Substance Supply
Employment Type:
Contract
Duration:
1+ year with likely extensions and/or conversion to a permanent position.
Rate:
$38 - $42/hour W2
Posting Date:
02/26/2025
Notes:
Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description Our ideal candidate will have:
5+ years of experience and a B.S.
Must have Analytical Equipment Troubleshooting
Must have Commissioning, Qualification, and Validation of Analytical Equipment
Must have Manufacturing Support
Responsibilities
The Sr. Engineer, Analytical will lead the troubleshooting and vendor support for a wide variety of analytical equipment that supports manufacturing.
Scope includes devices such as cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers.
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 drive continuous improvement activities.
Day to Day Responsibilities
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, password management
Support of different equipment in multiple buildings within the client’s Thousand Oaks campus
Top Must Have Skill Sets
5+ years of experience and a B.S.
Must have Analytical Equipment Troubleshooting
Must have Commissioning, Qualification, and Validation of Analytical Equipment
Must have Manufacturing Support
Basic Qualifications
BS in Engineering, Biotech, Chemistry, or Equivalent
Previous experience in a biotech/pharmaceutical industry with focus on usage and/or analytical equipment of specified equipment
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
Red Flags
Less than 3 years of experience
Experience that does not include analytical / in-process testing equipment
Experience that does not include hands-on troubleshooting and root cause analysis
Why is the Position Open? Supplement to the teams current workload
Interview Process Initial Interview, then Panel
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
#J-18808-Ljbffr
Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477)
Location:
Thousand Oaks, CA 91320
Business Unit:
Facilities and Equipment Drug Substance Supply
Employment Type:
Contract
Duration:
1+ year with likely extensions and/or conversion to a permanent position.
Rate:
$38 - $42/hour W2
Posting Date:
02/26/2025
Notes:
Only qualified candidates need apply.
3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description Our ideal candidate will have:
5+ years of experience and a B.S.
Must have Analytical Equipment Troubleshooting
Must have Commissioning, Qualification, and Validation of Analytical Equipment
Must have Manufacturing Support
Responsibilities
The Sr. Engineer, Analytical will lead the troubleshooting and vendor support for a wide variety of analytical equipment that supports manufacturing.
Scope includes devices such as cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers.
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 drive continuous improvement activities.
Day to Day Responsibilities
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, password management
Support of different equipment in multiple buildings within the client’s Thousand Oaks campus
Top Must Have Skill Sets
5+ years of experience and a B.S.
Must have Analytical Equipment Troubleshooting
Must have Commissioning, Qualification, and Validation of Analytical Equipment
Must have Manufacturing Support
Basic Qualifications
BS in Engineering, Biotech, Chemistry, or Equivalent
Previous experience in a biotech/pharmaceutical industry with focus on usage and/or analytical equipment of specified equipment
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
Red Flags
Less than 3 years of experience
Experience that does not include analytical / in-process testing equipment
Experience that does not include hands-on troubleshooting and root cause analysis
Why is the Position Open? Supplement to the teams current workload
Interview Process Initial Interview, then Panel
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
#J-18808-Ljbffr