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Principal Systems Engineer (JP7865)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Principal Systems Engineer (JP7865)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 28 October 2020
Note: Remote until COVID-19 restrictions are lifted.
 
3 Key Consulting is hiring a Principal Systems Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • Candidate will be working remote until the site reopens then required to be on site.
  • Masters/Bachelors 5+years OR Doctorate 3+ years of System Engineering experience in Drug Delivery or Aerospace.
  • Prefers the candidate to have experience in electromechanical drug delivery devices.
  • Prefers the candidate to have experience in requirements management tool such as DOORS.
  • The Principal Systems Engineer guides the identification, development, commercialization and improvement of drug delivery technologies to provide efficient patient experience in administration of the client’s therapeutic products.
  • The PSE will report to our Director of Systems Engineering & Risk Management.
  • As a leader in the organization, the PSE will ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture.
  • The PSE will work in collaboration with commercial and research colleagues in identification of user needs from market insights.
  • The PSE will lead creation and management of system requirements, development of system architecture, and integration of subsystems. This will require ensuring robust system architecture across the interactions, dependencies, and interfaces of subsystems.
  • The PSE will lead integration of the system through clinical and market entry.
  • The successful candidate will have demonstrated strength and success in managing interactions with key partners and colleagues from across process development, operations, research and development, and global commercial organizations to ensure accurate capture of the voice of customer and business into user needs.

    Role Responsibilities:
  • Lead development of robust drug delivery systems and coordinated development efforts utilizing best Systems Engineering principles in combination product development cycles.
  • Lead formal and ad-hoc technical and design reviews for the coordinated system.
  • Orchestrate system definition in conformance to global regulatory principles and best engineering methods including User Needs and System Design Inputs.
  • Responsible for DHF development and transparency of structure across platform, combination product, and vendor structures to ensure quality and visibility.
  • Owns integration of requirements, risks, and implemented mitigations through downstream design outputs.
  • Drives system verification and validation strategies across platform and brand-specific presentations.
  • Owns system performance & reliability targets and subsystem allocations.
  • Provides authorship and expert technical leadership for regulatory filings.
  • Responsible for mentoring, supervision, and advised professional development of more junior engineers.

Top Must have Skill Sets:
  • Solid knowledge of systems engineering principles, preferably in biotechnology but also in other industries.
  • Good experience working in cross-functional teams.
  •  Successful experience managing multiple projects in a deadline driven environment.
 
Employee Value Proposition:
Leading in drug delivery devices to develop new products - exposure to different departments & leadership
 
Red Flags:
1. Lack of systems engineering experience
2. Lack of experience working in cross-functional teams
 
Interview Process:
Phone interview & Video. 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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