Validation Specialist - Glassware Washer Lab. equipment
CIS International LLC
- Barceloneta, PR
- Autónomo
- Tiempo completo
The Validation Specialist will support the validation of the new Glassware Washer in the QC Laboratory of a pharmaceutical industry in Barceloneta, PR. This full time and full on-site project assignment will support an ongoing project. Proven experience in Glass Washer equipment and process validation is required.System to be used: Miele Model PLW 8615. This is a Laboratory Glassware Washer designed to cleaning, rinsing, and drying of llaboratory glassware, utensils and similar categorized components using water-based media.Responsibilities: * LEVA Documentation, Discrepancy and Risk Assessment: Develop all validation deliverables not limited to the following: Roles Assignment Log, Validation Plan, User Requirements, Risk Assessment, Configuration Specifications, Part 11 Assessment, URS, IOQ, PQ, Validation Summary Report and other) for the validation of Equipment.
- Vendor Equipment Start up and IOQ Execution: Support during Vendor Start up and vendor IOQ Execution.
- SOP: Generation of Operational and administration Procedures.
- PM, Calibration and Spare Parts: Incorporate equipment in PM, CAL & Spare Parts Program.
- Generate Weekly Reports: Project Status Report
- Support Any Drawings Update: Redlines of Drawings
- Support other tasks as assigned.
- Bachelor´s degree in Science, Engineering or Administration
- 3-5 years of direct related experience in validation of Glassware Washers or similar equipment to be used in a GxP process - Laboratory area in a pharmaceutical manufacturing environment.
- Good technical skills, able to learn the new technology and good communication and organization skills.
- Full time, full on site assignment in Barceloneta, PR
- Professional services contract classification
- 3 months of this first assignment
- Administrative shift and willing to work non administrative hours.