CQV Lead

We appreciate your interest in a career at AM Life Science. Please complete the job application down at the bottom of this page:

Current Open Locations
Greater Boston Area

process engineerOverview

CQV Lead candidate must be a highly motivated leader with solid interpersonal skills that allow them to collaborate well with various individuals, groups and departments, in addition to a technical foundation.

The ideal candidate:

  • would be able to problem solve and communicate effectively in a fast-paced manufacturing environment
  • would also need to feel comfortable undertaking increasing responsibility, delegating tasks and managing team members, yet be efficient in the completion of the requisite routine tasks as well
  • 10-15 years of experience within the Biotech/ Pharmaceutical/ Medical Device Manufacturing fields, or equivalent
  • should also be able to demonstrate hands-on technical and technical writing proficiency

Key Requirements and Technology Experience

  • A minimum of a Bachelor’s degree in Chemical or Mechanical Engineering, Chemistry, Biochemistry, and/or related discipline is required. Master’s degree a plus.
  • Experience with Single Use Technology/Single Use Mixers, Tff Skids, UF Skids, Bioreactors
  • Comfortable presenting to and leading meetings with Senior Leadership
  • A strong background in validation (and statistical tools such as Sampling Plans, Experimental Design and Optimization) is required.
  • Knowledge of current and applicable GMP regulations is required. Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.
  • Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.
  • Must be analytical, detail-oriented and able to interact with individuals of all levels.
  • Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred.
  • ASQ Certification or equivalent is preferred.