Principal/Senior Process Engineer

Company: DSJ Global
Location: Boston
Posted on: May 29, 2023

Job Description:

Job Title: Senior/Principal Engineer I, External ManufacturingLocation: Boston, MAJob Type: Full-timeOverview:We are seeking a highly skilled Senior/Principal Engineer I to join our External Manufacturing team. The successful candidate will be responsible for leading technology transfer, process improvements, and implementation efforts at external manufacturing sites. The candidate should have experience executing projects with equipment changes, authoring commissioning protocols, and reviewing Factory Acceptance Testing (FATs) and Site Acceptance Testing (SATs). The candidate should also have a good understanding of Good Engineering Practices (GEP), and be able to mentor process engineers. Experience with upstream and downstream process development in cGMP biomanufacturing is required.Responsibilities:

• Lead technology transfer efforts for new products and processes at external manufacturing sites
• Identify and implement process improvements at external manufacturing sites to increase efficiency and quality
• Execute projects with equipment changes, ensuring they meet regulatory requirements
• Author commissioning protocols and review Factory Acceptance Testing (FATs) and Site Acceptance Testing (SATs)
• Coordinate with vendors on system designs to ensure compliance with cGMP regulations
• Ensure a good understanding of Good Engineering Practices (GEP) in the implementation of projects
• Mentor process engineers and provide technical guidance on process improvements
• Experience with upstream and downstream process development in cGMP biomanufacturingRequirements:
  • Bachelor's or Master's degree in Chemical Engineering, Biomedical Engineering, or related field
  • 6+ years of experience in process engineering supporting cGMP biomanufacturing
  • Experience leading technology transfer efforts and implementing process improvements at external manufacturing sites
  • Hands-on experience with commissioning protocols, FATs, and SATs
  • Knowledge of regulatory requirements for cGMP biomanufacturing
  • Good understanding of Good Engineering Practices (GEP)
  • Experience with upstream and downstream process development
  • Excellent communication skills and ability to work collaboratively with cross-functional teamsWe offer a competitive salary and benefits package, as well as opportunities for growth and development within our fast-paced environment.

Keywords: DSJ Global, Boston , Principal/Senior Process Engineer, Engineering , Boston, Massachusetts