Biologics Engineer

Company: System One
Location: New Brunswick
Posted on: November 13, 2024

Job Description:

Job Title: Biologics Engineer
Location: New Brunswick, NJ
Hours/Schedule: Normal business hours
Type: Contract

Responsibilities

• Support TT Lead for one or more projects
  
• Actively participates in TT meetings, collaborating with cross-functional group.
  
• Responsible for detailed reviews of project documents such as protocols, reports, risk assessments, and MBRs.
  
• Provides assistance to sites to review/resolve quality events as needed.
  
• Collaborate on TT project definition and support chartered projects as needed.
  
• Identifies TT issues/risks and proposes ideas for issue resolution. Supports issue resolution as needed.
  
• Support Product Champion Cluster
  
• Support DV of various product TTs and lifecycle projects.
  
• Support improvement projects for Product Champion group.
  
• Identify opportunities for improvement and provide ideas to implement.
  
• Collaborate with Product Champions and work together to learn about different products and implement various improvements.
  
• Reporting Relationship Reports to Product Champion Cluster Lead
  
  
  Requirements
  Required:
  
  
• Knowledge in Biologics/sterile liquid drug products, aseptic processing
  
• Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer
  
• Ability to serve as a technical expert for Drug Product manufacturing
  
• Strong critical thinking, technical writing, and verbal communication
  
  
  Demonstrated ability to:
  
  
• Work in a matrix environment and effectively support the decentralized manufacturing function.
  
• Effectively collaborate with other functions
  
  
  Desired:
  
  
• Thorough knowledge of quality systems, Quality by Design, validation principles for product and engineering design and process control fundamentals
  
  
  Education/Experience/ Licenses/Certifications:
  
  
• Required Bachelor's degree in engineering/science-related field with 3-5 years of relevant experience. Time spent in advanced degree program may consider as equivalent experience.
  
  
  Benefits
  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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Keywords: System One, Danbury , Biologics Engineer, Engineering , New Brunswick, Connecticut