Design Control Engineer Ii

pfizer.co.ke

St.Louis, MO, US
Base: $68,600.00 - $114,300.00; bonus/equity: 7.5%...
Design control lifecycle management
Combination product development
Quality and regulatory standards
The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle

Job Summary

  • The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
  • Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external.
  • We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

Matching Summary

The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.

Salary

Base: $68,600.00 - $114,300.00; Bonus/Equity: 7.5% bonus target; Benefits: 401(k) with match, paid time off, health benefits

Skills & Requirements

Must-have

  • Design control lifecycle management
  • Combination product development
  • Quality and regulatory standards
  • ISO 9001, ISO 13485, ISO 14971
  • 21 CFR 820, ISO 11040
  • EU Medical Devices Directive
  • EN 62366, EU Medical Devices Regulation

Nice-to-have

  • US and global regulations knowledge
  • FDA and ICH guidance
  • Syringes/injectors standards
  • Device risk management expertise
  • Human Factors Engineering - Usability Engineering
  • Project management methodologies
  • Device assembling manufacturing process

Key Requirements

  • BS degree with 3+ years experience or MS degree with 0+ years experience
  • Experience in Pharmaceutical Combination Product and/or Device industries
  • Working knowledge of relevant ISO and CFR standards
  • Independent work with minimal supervision
  • High attention to technical details and accuracy
  • Ability to prioritize and work on multiple tasks
  • Collaborative work in cross-functional teams
  • Excellent communication and interpersonal skills
  • Proficiency in general computer software
  • Understand Good Manufacturing Practices (GMP)

Work Rights

Permanent work authorization in the United States

Tailored Resume

Cover Letter