Validation Engineer
Flexible & Integrated Technical Services View all jobs
- Añasco, PR
- Permanent
- Full-time
- Bachelor's Degree in Engineering and at least three (3) years of previous exposure to Validation or Quality Engineering activities within the Pharmaceutical or Medical Devices industry.
- Bilingual, Spanish and English (good communication)
- Shift: Administrative & according to business needs
- Experience in:
- Approving or reviewing change controls, validation plans, IQ/OQ/PQ protocols and Reports and SOPs changes.
- Writing and reviewing IQ/OQ/PQ protocols and summary reports.
- Utilities qualification and associated protocols/reports
- cGMP, FDA regulations, and ISO 13485 requirements
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
- Review, approve, and manage change controls to assess technical impact, validation status, and regulatory risk.
- Develop, review, and execute validation strategies and plans for equipment, processes, and utilities.
- Author, review, and approve IQ/OQ/PQ protocols and summary reports.
- Review/approve utilities protocols and qualification documentation (e.g., AHU, City Water, Electricity).
- Review and Approve validation-related procedures, work instructions, and templates.
- Support deviation investigations, and risk assessments related to validated systems and processes.
- Collaborate with cross-functional teams to ensure validation deliverables are completed on schedule.