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.