Project Engineer
Flexible & Integrated Technical Services Ver todas las vacantes
- Añasco, PR
- Permanente
- Tiempo completo
- Bachelor's Degree in Engineering and a minimum of six (6) years of experience within the Pharmaceutical or Medical Devices industry.
- Bilingual: Spanish and English
- Shift: Administrative & according to business needs
- Experience in:
- Facility Validation
- HIPPA Filtration
- Generating and executing validation documentation (URS, FRS, SDS, IQ/OQ/PQ, Validation Plans, SOPs).
- FDA, GMP, ISO, OSHA, EPA requirements, and GAMP 5 Computer Systems Validation lifecycle.
- 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?
- Plan, develop, and implement documentation, procedures, and training programs to support the Engineering and Validation teams.
- Lead and actively participate in the Computer Systems Validation (CSV) Life Cycle for regulated projects, including requirements definition, risk assessments, traceability, protocol development, testing, and deviation management.
- Generate and maintain validation documentation such as Validation Plans, URS, FRS, SDS, Traceability Matrix, validation protocols (FAT/SAT/IQ/OQ/PQ), and final reports.
- Perform and document validation testing, statistical data analysis, and develop statistically based sampling plans for inspections and validations.
- Review and approve validation protocols, executions, and completion reports for new and existing automated and computerized systems.
- Troubleshoot automation and computer system issues encountered during validation activities and recommend process or quality improvements.
- Investigate, document, and resolve non-conformances, protocol deviations, and CAPAs, ensuring timely and compliant closure.
- Manage equipment installation, automation software modifications, vendor coordination, budgeting, procurement, training, and system start-ups.
- Lead validation process improvement initiatives, oversee validation contractors, and generate performance metrics and trending reports for management reviews.
- Collaborate cross-functionally with Manufacturing, Engineering, Quality, Regulatory, and external partners, and support regulatory submissions and inspections (FDA, ISO, Notified Bodies, corporate audits).