Job Summary:
We are seeking an experienced professional to fill the role of a Validation Specialist. The successful candidate will have a strong background in validation and experience working with global brands.
* Perform Qualification and Validation of Manufacturing Equipment, Quality Control equipment, and Supply Chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications.
* Develop and maintain a validation maintenance program to ensure Good Manufacturing Practices (GMP) Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Processes remain in a validated and controlled state.
* Coordinate the scheduling of validation execution and analyze test results against pre-determined acceptance criteria.
* Collaborate with cross-functional teams to ensure a specific product meets current regulation and quality standards.
* Prepare, maintain, and review validation documentation such as Critical Quality Verification (CQV) documentation for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Investigate validation protocol discrepancies to identify root causes of validation test or production problems.
Requirements:
* Bachelor's or Master's degree in Engineering
* 3-7 years of experience or related equivalent work experience
* Experience with Current Good Manufacturing Practices (cGMPs) and Good Engineering Practices
* Knowledge of automation validation preferred
* Knowledge of Quality Control equipment qualification a plus