Validation Specialist
- Puerto Rico
- Permanente
- Tiempo completo
We are seeking a highly skilled Validation Consultant with proven experience in the validation of Glassware Washers or similar laboratory equipment used in GxP-regulated environments. The ideal candidate will have strong technical capabilities, the ability to quickly learn new technologies, and excellent communication and organizational skills to ensure compliance, accuracy, and efficiency in all validation activities.Key Responsibilities:Perform LEVA documentation, discrepancy resolution, and risk assessment.Support vendor equipment start-up and execute Installation and Operational Qualifications (IOQ).Develop Standard Operating Procedures (SOPs) for equipment operation and administration.Coordinate and document Preventive Maintenance (PM), calibration activities, and spare parts management.Prepare and submit weekly project progress reports.Review and update equipment drawings, including redlines and revisions.Perform additional tasks as assigned by the client to support project objectives.Qualifications:Bachelor’s degree in Engineering, Life Sciences, or related technical field (or equivalent experience).Experience in the validation of Glassware Washers or comparable laboratory equipment in GxP processes.Strong understanding of regulatory requirements (cGMP, GxP, FDA, EU guidelines).Excellent technical writing, communication, and organizational skills.Ability to work independently and collaboratively with cross-functional teams.Work Environment:Onsite client location in a regulated facility.May require flexible scheduling based on project timelines."Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.Powered by JazzHR