Associate Engineer Biotech Product Complaint JP13929
Associate Engineer Biotech Product Complaint JP13929
Posted on :
18-04-2025
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1 Vacancy
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Hourly Salary
$ 32 - 36
Vacancy
1 Vacancy
Posted on :
18-04-2025
Job Description
Job Title: Associate Engineer Biotech Product Complaint (JP13929
Location:Thousand Oaks CA. 91320 Hybrid
Business Unit:Complaints Trending
Employment Type: Contract
Duration:1 years with possible extensions or conversion to FTE
Rate: $32 $36/hour W2
Posting Date:04/11/2025
Notes:Must be local to be onsite.
3 Key Consulting is recruiting anEngineerfor a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer in the Complaints Trending and Investigation group. In support of the companys mission to serve patients the Complaints Trending and Investigation group is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize patient experience.
The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner SEM material analysis and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and crossfunctional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing data gathering and analysis as well as supporting/leading root cause analysis.
S/he will also support the implementation validation and operation of the equipment in the CT&I lab providing personnel training on the use of the equipment developing and updating equipment procedures participating in the monthly lab safety inspection and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
Responsibilities:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Why is the Position Open
Supplement additional workload on team
Red Flags:
Short timer employment
No technical or engineering experience/education
Interview Process:
1st phone interview with hiring manager
2nd virtual interview with hiring manager and team.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location:Thousand Oaks CA. 91320 Hybrid
Business Unit:Complaints Trending
Employment Type: Contract
Duration:1 years with possible extensions or conversion to FTE
Rate: $32 $36/hour W2
Posting Date:04/11/2025
Notes:Must be local to be onsite.
3 Key Consulting is recruiting anEngineerfor a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer in the Complaints Trending and Investigation group. In support of the companys mission to serve patients the Complaints Trending and Investigation group is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize patient experience.
The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner SEM material analysis and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and crossfunctional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing data gathering and analysis as well as supporting/leading root cause analysis.
S/he will also support the implementation validation and operation of the equipment in the CT&I lab providing personnel training on the use of the equipment developing and updating equipment procedures participating in the monthly lab safety inspection and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
Responsibilities:
- Perform device assessments of complaints and document results in a report.
- Perform root cause analysis investigations for mechanical and/or electromechanical products
- Complete evaluation and deliver assessment report on time per Companys requirements.
- Support the implementation and management of the lab infrastructure including all equipment used for investigations
- Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
- Support characterization testing and data gathering for investigations
- Masters or bachelors in engineering Science or Biomedical 2 years of experience in complaints investigation within a development manufacturing postmarket or equivalent environment
- Experience in lab environment
- Demonstrated competency in root cause analysis methodology
- Experience with assessment writing process and test development and and writing standard operating procedures (SOP)
- Strong technical writing and interpersonal skills
- Resultsdriven and detailoriented
Top Must Have Skill Sets:
- Strong technical analytical and problemsolving skills
- Strong interpersonal communication and teamwork skills
- Skills and experience in lab environment
Day to Day Responsibilities:
- Perform device assessments of complaints using equipment such as CT scanner microscope and other measurement/imaging equipment in a laboratory environment and document results in a report.
- Onsite 80 must be available to go onsite when needed.
Why is the Position Open
Supplement additional workload on team
Red Flags:
Short timer employment
No technical or engineering experience/education
Interview Process:
1st phone interview with hiring manager
2nd virtual interview with hiring manager and team.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
IC
Employment Type
Hourly
Key Skills
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