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Engineer (Biotech)

Regulatory Connect
Boston, MA, United States
Full-time

Job Title Engineer (Biologics)

Location - MA

Contract

We are seeking a dynamic and motivated Process Engineer to join our clients team. In this role, you will lead critical manufacturing process initiatives, driving process efficiencies and quality improvements.

If you have a passion for biologics or antibody drug conjugation manufacturing and thrive in a fast-paced environment, we want to hear from you.

Key Responsibilities :

  • Lead projects focused on improving manufacturing processes, increasing yield, reducing cycle time, and driving cost reduction.
  • Utilize statistical process control methodologies to gather and analyze process data. Develop action plans to enhance process robustness, prevent product loss, and control quality.
  • Provide technical support to resolve shop floor issues, ensuring smooth operational workflows.
  • Lead structured investigations to identify root causes of process issues and develop scientifically sound recommendations.
  • Collaborate with cross-functional teams on site initiatives such as continuous improvement, capacity increases, and process remediation.
  • Manage small to medium-sized projects, including project coordination, reporting, and team communication.
  • Lead process validation efforts for operational changes, new materials, or technologies.
  • Maintain up-to-date product and process documentation, ensuring compliance with internal procedures and regulations.
  • Support regulatory audits by providing technical expertise and documentation.
  • Champion EHS performance and compliance through active participation in EHS programs.

Qualifications :

  • BS or MS in Chemistry, Biology, or Engineering (Chemical, Mechanical, Bio-chemical).
  • Relevant technical experience in Process, Manufacturing, or Project Engineering.
  • Strong knowledge of biologics or antibody drug conjugation manufacturing processes.
  • Excellent problem-solving skills and experience with continuous improvement methodologies.
  • Strong written and verbal communication skills in English.
  • Experience with statistical process control and technical writing.

Scope of Work :

  • Provide technical support on the shop floor and contribute to the execution of experimental and validation runs.
  • Gather and analyze process data to develop action plans for process improvements and quality control.
  • Maintain compliance by ensuring all process documentation is up to date and aligned with regulatory standards.
  • Prepare reports and documentation for regulatory agencies, including Annual Product Reviews.

Capabilities :

  • In-depth knowledge of biologics and ADC manufacturing.
  • Strong problem-solving and project management skills.
  • Technical writing proficiency for scientific reports and documentation.
  • 11 days ago
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