Engineer Biopharma Medical Device JP10078
Engineer Biopharma Medical Device JP10078
Posted on :
10-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
Job Title:Engineer Biopharma Medical Device (JP10078
Location:Thousand Oaks Ca.
Employment Type:Contract
Business Unit: Physical Testing Systems Development
Duration:18 months with possible extension of conversion to FTE
Posting Date:04/25/2022
3 Key Consulting is hiring Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Engineer in Combination Product Operations (CPO) Physical Testing Systems (PTS) is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products devices primary containers and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product processes tooling or equipment introduction to improve quality and reliability and reduce cost.
Phases of projects include developing combination product test methods providing key expert support for qualification validation transfer and life cycle support of methods for manufacturing new product introduction training and production support.
Why is the Position Open
Staff Augmentation.
Top MustHave Skill Sets:
Day to Day Responsibilities:
Employee Value Proposition:
Career opportunity/Growth
Red Flags:
No Solidworks experience
No technical writing experience
No B.S. degree in technical field
Interview process:
Phone screen followed by interview panel
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Location:Thousand Oaks Ca.
Employment Type:Contract
Business Unit: Physical Testing Systems Development
Duration:18 months with possible extension of conversion to FTE
Posting Date:04/25/2022
3 Key Consulting is hiring Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Engineer in Combination Product Operations (CPO) Physical Testing Systems (PTS) is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products devices primary containers and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product processes tooling or equipment introduction to improve quality and reliability and reduce cost.
Phases of projects include developing combination product test methods providing key expert support for qualification validation transfer and life cycle support of methods for manufacturing new product introduction training and production support.
Why is the Position Open
Staff Augmentation.
Top MustHave Skill Sets:
- Solidworks experience
- Technical Writing
- Qualification/validation experience
Day to Day Responsibilities:
- Develop qualify and validate GMP physical test methods for vials prefilled syringes and injection devices.
- Work in teams to transfer new combination product test method and assembly requirements to manufacturing by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
- Develop qualify validate and transfer new equipment software systems and methods.
- Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
- Provide expert support for investigations as well as new process development required to improve manufacturing operations.
- Coordinate test method development and delivery with selected contractors.
- Ensure that qualification parameters are met for product assembly 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 process equipment.
- Provide expert training to individuals in the operation and maintenance of processes test methods and equipment introduced to Quality Control and/or 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).
- Generate/author and own the Test Method documents.
- Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
- Perform other duties as required by the Group Manager
- Comply with the requirements responsibilities and authority as required
- Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
- Networks internally to ensure alignment commitment to project objectives and timelines as well as to ensure effective of projects
- Networks with manufacturing quality and regulatory organizations both internal and external to company
- Drives the crossfunctional communication and integration of information to optimize decision making issue resolution and change management throughout project lifecycle
- Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
- Collaborates with other functional leaders to ensure project success momentum and commitment
- Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
- Integrates partner/vendor timelines with Clients timelines as appropriate
Employee Value Proposition:
Career opportunity/Growth
Red Flags:
No Solidworks experience
No technical writing experience
No B.S. degree in technical field
Interview process:
Phone screen followed by interview panel
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
Key Skills
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