What are the responsibilities and job description for the Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477) position at 3 Key Consulting?
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 with have:
• 5 YOE and B.S.
• Must have Analytical Equipment Troubleshooting.
• Must have Commissioning, Qualification, and Validation of Analytical Equipment.
• Must have Manufacturing Support
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. Responsibilities include:
• Working 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 Thousand Oaks campus
Top Must Have Skill Sets:
• 5 YOE and B.S.
• Must have Analytical Equipment Troubleshooting.
• Must have Commissioning, Qualification, and Validation of Analytical Equipment.
• Must have Manufacturing Support
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
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.
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 with have:
• 5 YOE and B.S.
• Must have Analytical Equipment Troubleshooting.
• Must have Commissioning, Qualification, and Validation of Analytical Equipment.
• Must have Manufacturing Support
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. Responsibilities include:
• Working 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 Thousand Oaks campus
Top Must Have Skill Sets:
• 5 YOE and B.S.
• Must have Analytical Equipment Troubleshooting.
• Must have Commissioning, Qualification, and Validation of Analytical Equipment.
• Must have Manufacturing Support
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
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.
Salary : $38 - $42