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Validation Engineer, Biopharma (JP9227)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Validation Engineer, Biopharma (JP9227)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: 
MEM Test Automation
Duration: 1+ years with likely extensions
Posting Date: 09/29/2021

Note: The work needs to be partially onsite
 
3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly method development and experimental design. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Assist with project definition by performing engineering studies and assessment for drug delivery systems. Perform field evaluations of existing systems and provide engineering design recommendations. Design and development of physical test methods with respect to container and combination product integration of drug delivery systems. Capable of machine design from initial conception through fabrication and into implementation.


Skills: automation testing, manufacturing experience, mechanical systems modeling, fabrication technique, fixture design experience, Solidworks, technical writing, strong communication skills.
 
Why is the Position Open?
Supplement additional workload on team.
 
Top Must-Have Skill Sets:

Bachelor’s degree in an engineering field, technical writing, engineering measurement

Preferred Skills:
Master's degree in mechanical or electrical engineering, statistical analysis, optical measurement devices, test method development, CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ, teamworking and communication skills.


Day to Day Responsibilities:
  • Evaluating and assessing the existing test method, both their documentation and their implementation in the field.
  • Modifying and improving the test methods, if necessary.
  • Creating a qualification, validation and transfer plan for the test methods, when required.
  • Performing and operating the tests required for qualification, validation and transfer of the methods.
  • Creating training documents.
  • Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.
     
Employee Value Proposition:
The chance to gain valuable hands-on experience as well as expand knowledge in the field.

 
Interview process:
Phone screening interview and Online Video interview.
 
We invite qualified candidates to send your resume to 
resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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