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Job Title: Engineer, Measurement and Test Method Validation (JP13658)
Location: Thousand Oaks, CA. 91320
Business Unit: MEM Test Automation
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 02/05/2025.
Notes: Only qualified candidates need apply. Onsite. candidates must be within a commutable distance
3 Key Consulting is hiring! We are recruiting an Engineer, Measurement and Test Method Validation for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The ideal candidate for this Test Method Validation Engineering role will have:
• Bachelor’s degree in Engineering (Mechanical Engineering preferred)
• 2+ years of industry experience (internship experience is acceptable).
• Solid understanding of measurement concepts and engineering measurements
• Basic knowledge of statistics, including confidence intervals and statistical analysis tools.
• Either direct experience in test method validation or strong analytical skills and the ability to learn quickly will be considered.
• Experience in regulated industries such as pharmaceuticals, medical devices, or other compliance-driven environments will have an advantage, as 70% of the role involves documentation and regulatory compliance.
• RQPQ (Risk, Qualification, Process Qualification)
• Installation Qualification (IQ) Operational Qualification (OQ, PQ) is beneficial but can be developed on the job.
• Strong problem-solving skills, adaptability, and a demonstrated ability to work in a highly regulated and collaborative environment are key for success in this role.
Test Method and Validation Engineer Position. This position involves support of senior staff in design, development, modification, qualification, validation, and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers and packaging components. The particular focus would be on automated dimensional measurements methods, advanced methods for measuring functional attributes of injection systems and enhancing the visual inspection methods.
Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university. They are also expected to have strong technical writing skills and be familiar with different engineering measurement techniques and equipment.
Candidates having a master’s degree in mechanical or electrical engineering with the following skills are preferred:
• Statistical analysis
• Gage R&R
• Optical and automated measurement devices
• Test method development
• CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ.
• Teamworking and communication skills is required for this position.
Top Must Have Skill Sets:
• Bachelor’s degree in an engineering field
• Technical writing
• Engineering measurement
Day to Day Responsibilities:
• Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
• Creating new test methods and the required test fixtures.
• 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.
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Preferred Qualifications:
• Statistical analysis
• Gage R&R
• Optical and automated measurement devices
• Test method development
• CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ.
• Teamworking and communication skills is required for this position.
Red Flags:
• Candidate without Statistical Understanding.
• Candidates without general measurement knowledge.
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Phone screening interview by hiring manager, then two panel interview for selected candidates.
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: MEM Test Automation
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 02/05/2025.
Notes: Only qualified candidates need apply. Onsite. candidates must be within a commutable distance
3 Key Consulting is hiring! We are recruiting an Engineer, Measurement and Test Method Validation for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
The ideal candidate for this Test Method Validation Engineering role will have:
• Bachelor’s degree in Engineering (Mechanical Engineering preferred)
• 2+ years of industry experience (internship experience is acceptable).
• Solid understanding of measurement concepts and engineering measurements
• Basic knowledge of statistics, including confidence intervals and statistical analysis tools.
• Either direct experience in test method validation or strong analytical skills and the ability to learn quickly will be considered.
• Experience in regulated industries such as pharmaceuticals, medical devices, or other compliance-driven environments will have an advantage, as 70% of the role involves documentation and regulatory compliance.
• RQPQ (Risk, Qualification, Process Qualification)
• Installation Qualification (IQ) Operational Qualification (OQ, PQ) is beneficial but can be developed on the job.
• Strong problem-solving skills, adaptability, and a demonstrated ability to work in a highly regulated and collaborative environment are key for success in this role.
Test Method and Validation Engineer Position. This position involves support of senior staff in design, development, modification, qualification, validation, and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers and packaging components. The particular focus would be on automated dimensional measurements methods, advanced methods for measuring functional attributes of injection systems and enhancing the visual inspection methods.
Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university. They are also expected to have strong technical writing skills and be familiar with different engineering measurement techniques and equipment.
Candidates having a master’s degree in mechanical or electrical engineering with the following skills are preferred:
• Statistical analysis
• Gage R&R
• Optical and automated measurement devices
• Test method development
• CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ.
• Teamworking and communication skills is required for this position.
Top Must Have Skill Sets:
• Bachelor’s degree in an engineering field
• Technical writing
• Engineering measurement
Day to Day Responsibilities:
• Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
• Creating new test methods and the required test fixtures.
• 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.
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Preferred Qualifications:
• Statistical analysis
• Gage R&R
• Optical and automated measurement devices
• Test method development
• CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ.
• Teamworking and communication skills is required for this position.
Red Flags:
• Candidate without Statistical Understanding.
• Candidates without general measurement knowledge.
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Phone screening interview by hiring manager, then two panel interview for selected candidates.
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.