$79,400.00 - $132,400.00; bonus target of 7.5% of ...
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Design control for biologics
Prefilled syringe combination products
Quality and regulatory standards
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Pfizer is seeking a Design Control Engineer III to lead design control projects for biologic combination products at their locations in St. Louis, MO, or Andover, MA. Candidates should have a strong background in the pharmaceutical or medical device industries, with a focus on compliance, risk management, and cross-functional collaboration.
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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
Match Score: 75
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Pfizer is seeking a Design Control Engineer III to lead design control projects for biologic combination products at their locations in St. Louis, MO, or Andover, MA. Candidates should have a strong background in the pharmaceutical or medical device industries, with a focus on compliance, risk management, and cross-functional collaboration.
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Salary
$79,400.00 - $132,400.00; Bonus target of 7.5% of base salary; Comprehensive benefits package
Skills & Requirements
Must-have
Design control for biologics
Prefilled syringe combination products
Quality and regulatory standards
Risk management activities
Human factors engineering assessments
Regulatory submission data generation
Nice-to-have
Current US and global regulations
Syringes/injectors/luer connectors
Device risk management expertise
Human Factors Engineering - Usability Engineering
Project management methodologies
Key Requirements
BS degree with 6-8 years experience OR MS degree with 4-6 years experience
ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, EU Medical Devices Directive