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Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477)
Location: Thousand Oaks, Ca. 100% onsite.
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $44 - $50/hr. W2 with benefits
Posting Date: 12/12/2024
3Key Consulting is hiring! We are recruiting a Senior Engineer with Biotech Manufacturing and Process Equipment experience for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: The Sr. Engineer, Analytical will lead troubleshooting, vendor support, commissioning, qualification, validation, decommissioning, and project work associated with a wide variety of analytical equipment that supports manufacturing.
Job Description:
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 company 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.
Top Must Have Skill Sets:
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.
Why is the Position Open?
Supplement additional workload on team
Red Flags:
Interview Process:
1. First round: Screening with hiring manager.
2. Second round: Panel interview with senior engineers
We invite qualified candidates to send your resume to recruiting@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. 100% onsite.
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $44 - $50/hr. W2 with benefits
Posting Date: 12/12/2024
3Key Consulting is hiring! We are recruiting a Senior Engineer with Biotech Manufacturing and Process Equipment experience for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: The Sr. Engineer, Analytical will lead troubleshooting, vendor support, commissioning, qualification, validation, decommissioning, and project work associated with a wide variety of analytical equipment that supports manufacturing.
Job Description:
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 company 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.
Top Must Have Skill Sets:
- Analytical Equipment Troubleshooting
- Commissioning, Qualification, and Validation of Analytical Equipment
- Manufacturing Support
- 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 company campus
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.
Why is the Position Open?
Supplement additional workload on team
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
Interview Process:
1. First round: Screening with hiring manager.
2. Second round: Panel interview with senior engineers
We invite qualified candidates to send your resume to recruiting@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.
Regards,
3KC Talent Acquisition Team