Job Overview
This is an initial 11-month contract position.
* We are seeking a professional to oversee all validation activities, ensuring compliance with current regulatory requirements, cGMP and company SOPs.
* Validation/qualification activities will be performed for facilities, utilities, equipment, computerized systems, cleaning processes storage areas controlled temperature units (CTUs) and shipping
* A high level of QA oversight will be required for Commissioning Qualification and Validation (CQV) activities associated with the start-up project at our facility.
The ideal candidate will possess a BSc or BEng in a scientific or engineering-related discipline. For example biochemistry chemistry engineering They must have at least four-five years' experience in Quality Engineering/Quality Assurance/Quality Validations role for biologics or related pharmaceutical medical device manufacturing in a FDA/EU regulated environment There should be thorough understanding of validation requirements associated with cGMP manufacturing facilities strong technical aptitude and deep knowledge relevant regulations industry standards.