About the Role
We are seeking an experienced Validation Specialist to oversee validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. The ideal candidate will have a strong understanding of validation requirements associated with a cGMP manufacturing facility.
Responsibilities
* Ensure quality oversight of qualification/validation activities of all facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs) and shipping processes.
* Review and approve validation documentation and associated data.
* Provide support in Regulatory inspections and Client audits.
Requirements & Qualifications
* Bachelor of Science or Bachelor of Engineering degree in a Scientific or Engineering related discipline.
* Experience in Quality Engineering/Quality Assurance/Quality Validations role for Biologics or related pharmaceutical/ medical device manufacturing.