View all jobs
Engineer, Complaints Investigation (JP11741)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer, Complaints Investigation (JP11741)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Investigation
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $38 - $42/hour W2
Posting Date: 09/01/2023
Notes: Only qualified candidates need apply. Onsite 80% of time. Local candidates or candidates willing to relocate only.
3 Key Consulting is recruiting an Engineer for 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 Sr Engineer in Complaints Trending and Investigation group. The Complaints Trending and Investigation group at client is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the 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 cross-functional 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.
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
CANDIDATE MUST BE ONSITE AT LEAST 80% DURING THE WEEK DO NOT SUBMIT CANDIDATES LOOKING FOR REMOTE WORK
Interview Process:
One phone interview. Available to start interviewing immediately.
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: Complaints Investigation
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $38 - $42/hour W2
Posting Date: 09/01/2023
Notes: Only qualified candidates need apply. Onsite 80% of time. Local candidates or candidates willing to relocate only.
3 Key Consulting is recruiting an Engineer for 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 Sr Engineer in Complaints Trending and Investigation group. The Complaints Trending and Investigation group at client is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the 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 cross-functional 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.
Top Must Have Skill Sets:
- 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment (GMP setting complaint investigation highly preferable)
- Organized
- Able to meet deliverables on time
- Engineering degree preferred not required (technical degree is strongly preferred)
Day to Day Responsibilities:
- Help business with EFM implementation and alignment
- Help with month end deliverables and processes
- Help with quarter end deliverables
- Help with processes around implementation, when needed
- 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 client 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
Basic Qualifications:
- Master’s degree; OR
- Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR
- Associate degree and 6 years of related medical/biopharma development or Operations experience.
Preferred Qualifications:
- Master’s or Bachelor’s in Engineering, Science or Biomedical
- 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
- Experience in lab environment
- Demonstrated competency in root cause analysis methodology
- Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
- Strong technical writing and interpersonal skills
- Results-driven and detail-oriented
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
CANDIDATE MUST BE ONSITE AT LEAST 80% DURING THE WEEK DO NOT SUBMIT CANDIDATES LOOKING FOR REMOTE WORK
Interview Process:
One phone interview. Available to start interviewing immediately.
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.
Regards,
3KC Talent Acquisition Team