Job Title:  Engineer, Complaints Investigations - (JP11228)
Location: Thousand Oaks, CA. 91320
Employment Type:  Contract
Business Unit: Complaints Investigation
Duration: 1+ years (with likely extensions)
Posting Date: 1/09/2023
Notes: Only qualified candidates need apply.  Onsite 80%, must be available to go onsite when needed.  Local candidate or candidate willing to relocated to 91320



3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to the Sr Manager in Complaints Trending and Investigation group. In support of client’s mission to serve patients, 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 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.

Why is the Position Open?
Backfill.

Top Must-Have Skill Sets:

• Experience in technical investigation and root cause analysis
• Able to collaborate and communicate with cross functional team
• Master’s or Bachelor’s in Engineering, Science or Biomedical
• Experience in lab environment

Day to Day 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 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

Employee Value Proposition:
Career growth, opportunity

Red Flags:

• No engineering background or experience
• Lack of basic qualifications and must have skills

 

• Interview process:
  Phone screening (15-30 min with hiring manager)
• Video call / interview with cross-functional team (3-4 members, 30 min each)

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.