Supports process and product quality programs including process and software validations, equipment calibration programs and process monitoring activities, by writing simple verification/validation documents, executing qualification tests, compiling data, drafting summary reports, and reviewing validation documentation to ensure products are manufactured in accordance with applicable regulatory guidelines, manufacturer’s specifications, client’s specifications and VGXI’s requirements. Review, update and work with various departments to develop SOPs for existing and new equipment/ processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Support the validation function by assisting with the development of validation documentation, executing qualification protocols, compiling data, and writing reports.
- Support new product scale-up, process optimization, technology transfer, and process validation activities.
- Participate on project teams responsible for implementation of product enhancements.
- Maintaining validation schedules/timelines
- Maintains re-validation schedule and validation files.
- Mentor junior staff and support team growth though the supervision of assigned projects
- Monitor publications, presentations, etc., to stay current on all processing technology and recommend process improvements.
- Report back to QA Manager on the general status of operations and specific issues of concern as needed.
EDUCATION and/or EXPERIENCE
- Bachelor’s Degree or equivalent; or one to three years related experience and/or training; or equivalent combination of education and experience.
- Experience within a pharmaceutical/biologics environment is preferred.
- GMP experience is a plus.
- Software validation experience in a GMP environment is a plus.
Contract to hire position
VGXI is an Equal Opportunity Employer.