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Systems Engineer, Sr. - Biopharma Systems Engineering (JP10876)
Thousand Oaks, CA · Biotech/PharmaceuticalJob 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 cross-functional 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 Must-Have 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 in-person interview.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone 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 cross-functional 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 cross-functionally 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 Must-Have 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 in-person interview.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team