Engineer Biopharma Medical Device JP10473
Engineer Biopharma Medical Device JP10473
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 (JP10473
Location:Thousand Oaks CA. (Hybrid 50 onsite/remote)
Employment Type: Contract
Business Unit:PFS And Lyo Kit Platforms
Duration:1year with likely extensions or conversion to perm
Posting Date:06/23/2022
3 Key Consulting is hiring anEngineer Medical Drug Delivery Devicefor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Device Engineer will participate in the design development and lifecycle management related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing failure investigation leading and assessing design changes develop test procedures scaleup and global launch supplier development and continues improvement.
Scope includes mechanical delivery devices such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electromechanical delivery devices are maintained. The engineer will participate in cross functional teams leading device design activities such as developing product enhancements analytical failure analysis and implementing design solutions assessment of proposed changes product launches and defending inspection and follow through of commitments.
Essential skills and Responsibilities:
Basic Qualifications:
BS in Chemical/Biomedical Engineering Pharmaceutical Sciences Chemistry/Biochemistry or Biotechnology with 3 years of experience within the pharmaceutical/biotechnology industry.
Preferred Qualifications:
Why is the Position Open
Supplement additional workload on team.
Top MustHave Skill Sets:
Day to Day Responsibilities:
The device engineer will support a senior engineer on a variety of projects related to laboratory testing life cycle management and productbased initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols reports and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. FillFinish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.
Red Flags:
1. No laboratory experience or desire to work in a lab environment
3. No desire to work in crossfunctional team environment
4. No technical writing skills
5. No BS degree
Employee Value Proposition:
To work for a dynamic team
Interview process:
Webex with HM
Panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a 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. (Hybrid 50 onsite/remote)
Employment Type: Contract
Business Unit:PFS And Lyo Kit Platforms
Duration:1year with likely extensions or conversion to perm
Posting Date:06/23/2022
3 Key Consulting is hiring anEngineer Medical Drug Delivery Devicefor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Device Engineer will participate in the design development and lifecycle management related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing failure investigation leading and assessing design changes develop test procedures scaleup and global launch supplier development and continues improvement.
Scope includes mechanical delivery devices such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical and electromechanical delivery devices are maintained. The engineer will participate in cross functional teams leading device design activities such as developing product enhancements analytical failure analysis and implementing design solutions assessment of proposed changes product launches and defending inspection and follow through of commitments.
Essential skills and Responsibilities:
- Fully competent engineer in all conventional aspects of the subject matter functional area and assignments plans and conduct work requiring judgment in the independent evaluation selection and substantial adaptation and modification of standard techniques procedures and criteria and devises new approaches to problems encountered.
- Accountability of maintaining technical records within design history file associated with assigned products
- Develop Test Method generate and maintain design specification protocol & report writing prototyping DOE/SPC product optimization design verification & validation FMEA etc.
- Lead system level root cause investigation coordinate design improvements with development partners strategic planning and of design changes and improvements.
- Works with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications
- Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
- At a minimum familiar with the following standards and regulation:
- Quality System Regulation 21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements Council Directive 93/42/EEC
Basic Qualifications:
BS in Chemical/Biomedical Engineering Pharmaceutical Sciences Chemistry/Biochemistry or Biotechnology with 3 years of experience within the pharmaceutical/biotechnology industry.
Preferred Qualifications:
- Degree in the field of Mechanical or Biomedical
- Medical device industry experience and regulated work environment experience
- Background in developing and commercialization of medical devices and knowledge of manufacturing processes
- Strong understanding and experience in design controls failure investigation initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams
- Excellent written and verbal communication skill
Why is the Position Open
Supplement additional workload on team.
Top MustHave Skill Sets:
- Must have hands on Laboratory experience in a GLP Setting (Science or Engineering Lab)
- BS Degree in the field of Mechanical Chemistry Biomedical Engineering or any science degree
- Seeking a candidate with regulated work environment experience
Day to Day Responsibilities:
The device engineer will support a senior engineer on a variety of projects related to laboratory testing life cycle management and productbased initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols reports and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. FillFinish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.
Red Flags:
1. No laboratory experience or desire to work in a lab environment
3. No desire to work in crossfunctional team environment
4. No technical writing skills
5. No BS degree
Employee Value Proposition:
To work for a dynamic team
Interview process:
Webex with HM
Panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to take a 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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