Description

The Validation Manager has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Engineer is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any re-validation studies are performed.

Requirements

• B.S., or M.S. preferably in Chemical or Process Engineering or Biological or Pharmaceutical Science or other related science degree.

• 3+ years applicable experience preferably in a pharmaceutical, biopharmaceutical or IVD industry

• Knowledge of cGMPs or equivalent regulations

• Ability to make sound decisions about scheduling, allocation of resources, and balancing priorities

• Strong digital literacy required: shown understanding of Minitab; functional knowledge of Microsoft Outlook, Word, and Excel.

• Proven knowledge and experience with software systems and integration with the quality system.