Validation Lead – Oracle Process Manufacturing

Requirements

• Proven experience in validation testing within Oracle Process Manufacturing (OPM)
• Strong understanding of regulatory requirements including ICH Q9 Guidelines
• Familiarity with Computer System Validation (CSV) and Computer System Assurance (CSA) methodologies
• Experience in developing and executing validation protocols (IQ/OQ/PQ)
• Ability to collaborate effectively with cross‑functional teams
• Excellent documentation skills and attention to detail
• Experience with integration testing with systems like MES and ESB

• Oversee validation testing activities for Oracle Process Manufacturing modules such as recipe management, batch processing, and quality assurance
• Create and implement validation protocols in accordance with established methodologies
• Ensure adherence to relevant regulatory frameworks during validation efforts
• Work alongside diverse teams to establish testing strategies and criteria for acceptance
• Conduct integration testing with various enterprise platforms
• Accurately document testing results, deviations, and necessary corrective actions according to standard operating procedures
• Prepare for audits and address inspection inquiries regarding validation documentation

We are looking for a Validation Testing Specialist who possesses extensive knowledge in Oracle Process Manufacturing (OPM) to aid in our validation initiatives across manufacturing systems. Our Boston, MA/OH location offers a vibrant work environment where you will play a crucial role in ensuring compliance with industry regulations while producing high‑quality validation documentation and testing results. This position is for an initial duration of 12+ months, and we offer a competitive rate of $65 per hour along with an opportunity to work closely with talented professionals in the field.