Engineer Senior Validation Physical Test Methods Combination Devices - Hybrid JP12037
Engineer Senior Validation Physical Test Methods Combination Devices - Hybrid JP12037
Posted on :
11-04-2025
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Hourly Salary
$ 46 - 51
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title: Engineer Senior Validation Physical Test Methods Combination Devices Hybrid (JP12037
Location: Thousand Oaks CA. 91320
Business Unit: Physical Testing Systems Development
Employment Type: Contract
Duration: 6 monthss (with possible extensions)
Rate: $46 $51/hour W2
Posting Date: 12/18/2023
Notes: Only qualified candidates need apply. Hybrid Must be local to Thousand Oaks CA. as follows:
Monday Wednesday Friday (Remote)
Tuesday Thursday (On site) 8am 5pm (flex) / 7am 4pm
3 Key Consulting is recruiting an Engineer Senior Validation Physical Test Methods Combination Devices for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products devices primary container and secondary packaging components as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product process tooling or equipment introduction to improve product quality and reliability.
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:
Interview Process:
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 websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: Thousand Oaks CA. 91320
Business Unit: Physical Testing Systems Development
Employment Type: Contract
Duration: 6 monthss (with possible extensions)
Rate: $46 $51/hour W2
Posting Date: 12/18/2023
Notes: Only qualified candidates need apply. Hybrid Must be local to Thousand Oaks CA. as follows:
Monday Wednesday Friday (Remote)
Tuesday Thursday (On site) 8am 5pm (flex) / 7am 4pm
3 Key Consulting is recruiting an Engineer Senior Validation Physical Test Methods Combination Devices for a consulting engagement with our direct client a leading global biotechnology company.
Job Description:
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products devices primary container and secondary packaging components as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product process tooling or equipment introduction to improve product quality and reliability.
Top Must Have Skill Sets:
- Experience performing data analysis using statistical software (JMP Minitab)
- Experience modeling test fixtures reference samples on solidworks or any other CAD software
- Root cause analysis CAPA deviation
- Equipment method and test validation experience
- Technical writing experience
Day to Day Responsibilities:
- Assure transfer of new combination product test methods to QC or manufacturing by developing six sigma processes and compiling all required documentation.
- Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
- Apply core engineering principles to develop physical test methods for medical device and combination product systems.
- Perform data analysis to support method development qualification validation and transfer
- Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
- Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality reliability new product introduction cost saving).
- Coordinate gauge and equipment development and delivery with selected contractors.
- Ensure that qualification parameters are met for product assembly and performance requirements.
- Support development of cost estimates for new processes gauges and equipment development used in generation of capital request documentation.
- Generate procedures necessary to support department and new product equipment.
- Provide expert training to individuals in the operation and maintenance of processes gauges and equipment introduced to the manufacturing department (i.e. production operator mechanics process engineers).
- Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
- Excellent communication (written and verbal) and organizational skills
- Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
- Networks with manufacturing quality and regulatory organizations both internal and external to client
- Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
- Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
- Integrates partner/vendor timelines with client timelines as appropriate
Basic Qualifications:
- Doctorate Degree OR
- Masters Degree and 3 years of Engineering experience OR
- Bachelors Degree and 5 years of Engineering experience OR
- OAssociates degree and 10 years of Engineering experience OR
- High school diploma/GED and 12 years of Engineering experience.
Preferred Qualifications:
- M.S. or Ph. D. in Mechanical Aerospace Mechatronics Chemical or Biomedical engineering
- Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
- Experience with managing technical teams including setting priorities and leveling resources
- Technical writing experience
- Spanish language skills preferred
- Experienced with SolidWorks (or other 3DCAD software)
- Familiar with equipment and software IOQ
- Experience with process characterization scaleup technology transfer experience pFMEAs and dFMEAs
- Experience with change controls deviations CAPA
- Experience with combination products and device regulatory requirements
- Understanding of the six sigma process utilizing Minitab (or other statistical software packages) to solve statistical problems
- Work history with cGMPs regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
- Experience with machine controls (PLC HMI) and vision systems
Why is the Position Open
Supplement additional workload on team
Red Flags:
- No engineering background.
- No CAD background.
- No troubleshooting and root cause investigation experience.
- No data analysis experience.
- No technical writing experience
- Lack of experience working in technical team / team work
Interview Process:
- 1st initial phone screen
- 2nd interview in person panel
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 websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Hourly
Key Skills
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