CQV Lead

Location
Boston, MA, United States
Posted
Mar 02, 2021
Ref
1767704577
Hotbed
Lone Star Bio
Required Education
Bachelors Degree
Position Type
Full time
Overview

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.