Systems Engineer Sr - Biopharma Systems Engineering JP10876
Systems Engineer Sr - Biopharma Systems Engineering JP10876
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
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Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title:Systems Engineer Sr. Biopharma Systems Engineering (JP10876
Location:Thousand Oaks CA.
Employment Type: Contract
Business Unit:Final Product Technical Leads
Duration:2 years with likely extension or conversion to FTE
Posting Date:10/03/2022
Note: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered.
3 Key Consulting is hiring a Sr. System Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Systems Engineer (SE) works as part of crossfunctional program teams to deliver the technical content performance intellectual property and quality deliverables of a combination product development program. The SE understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied identifies technical risks and assists risk retirement activities on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
Responsibilities:
Why is the Position Open
Staff Augmentation / Need for additional team member
Top MustHave Skill Sets:
Day to Day Responsibilities:
Employee Value Proposition:
To work for a dynamic team
Red Flags:
1. No degree
2. No systems engineering experience
Interview process:
Phone screening followed by inperson 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.
Employment Type: Contract
Business Unit:Final Product Technical Leads
Duration:2 years with likely extension or conversion to FTE
Posting Date:10/03/2022
Note: Qualified candidates with either a strong Electrical Engineering Mechanical Engineering OR Systems/Software Engineering background need apply and will be considered.
3 Key Consulting is hiring a Sr. System Engineer for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
The Systems Engineer (SE) works as part of crossfunctional program teams to deliver the technical content performance intellectual property and quality deliverables of a combination product development program. The SE understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied identifies technical risks and assists risk retirement activities on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
Responsibilities:
- Work crossfunctionally with individuals and project teams in Marketing Operations and Development
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules
- Develop execute and review requirements documents design documents specifications development plans characterization plan verification and validation plans and other related product development documents for assigned projects.
- BS in Engineering and previous experience in a medical device industry
- 10 years current experience with engineering processes and procedures.
- 6 years of progressive experience as an engineer or scientist within the appropriate field of study (Systems Engineering)
- Creative problem solver and solution developer when presented with conflicting requirements business demands and technical risks/issues.
- Experience in combination product development.
Why is the Position Open
Staff Augmentation / Need for additional team member
Top MustHave Skill Sets:
- Prior Systems Engineering Experience
- Strong background in documenting requirements and providing traceability documentation for FDA Approval DOORS Requisite Pro or other similar requirements management software.
- Experience in combination product development.
Day to Day Responsibilities:
- On product core teams represent the best practices of systems engineering through consideration of the system as a whole rather than individual components of the system.
- Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones.
- Provide technical presentations at functional and cross functional settings.
- Utilize project planning and monitoring methods to ensure timely completion.
- Create own review and approve others completed design control deliverables
Employee Value Proposition:
To work for a dynamic team
Red Flags:
1. No degree
2. No systems engineering experience
Interview process:
Phone screening followed by inperson 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
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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