Position:  Process Engineer II, Manufacturing Science & Technology
Location:  Cambridge, MA
Job Id:  003
# of Openings:  1

Process Engineer II, Manufacturing Science & Technology

Summary:

This position will provide process engineering support for tech transfers of downstream operations (chromatography, Ultrafiltration/Diafiltration, and vial fill) to contract manufacturing organizations (CMOs) and for design, build, and validation phase of projects.

Key Duties & Accountabilities:
  • Support scale-up, technology transfer, and plant start-up activities. Includes onsite presence at our contract manufacturing organizations
  • Support ongoing manufacturing operations through process monitoring, trending, issue resolution, and identifying risks and opportunities for process improvement of downstream operations
  • Assist with evaluation of facility and equipment design for its ability to meet process requirements
  • Support regulatory filing updates
  • Support the development and execution of MS&T business processes and procedures such as data reviews, tech transfer protocols, and process control strategies
  • Performs other related duties and ad hoc projects as required
Core Competencies Required:
  • Work individually and as part of a team
  • Interpersonal/collaboration
  • Communication – oral and written
  • Analytical and strategic thinking
  • Ability to lead and influence others
  • Ability to adhere to strict guidelines in a regulated environment
  • Knowledge: Education, Experience, & Skills:
Basic Qualifications Required:
  • Bachelor’s degree in Engineering, life sciences, or equivalent with 5+ years’ experience
  • Master’s degree in Engineering, life sciences, or equivalent with 2+ years’ experience
  • PhD in Engineering, life sciences, or equivalent with 0 years’ experience
Preferred Skills:
  • Experience working in a process engineering role supporting protein purification within a biologics GMP manufacturing environment
  • In-depth understanding of equipment used in Single-Use biologics manufacturing, chromatography, and Ultrafiltration/Diafiltration
  • Strong technical ability demonstrated by experience in process design, data analysis and problem solving
  • Good knowledge of aseptic processing/techniques, and equipment validation
  • Experience supporting regulatory filings, and participation in regulatory inspections
  • Experience working with contract manufacturing organizations
Travel Commitment:
  • On average 20 to 25% travel will be required

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