Validation Specialist

Validation Specialist PQ Focus (E-Beam, Isolators, Filling Equipment) Position Overview We are seeking agile and hands‑on Characterization & Validation Scientists to support an accelerated project involving Performance Qualification (PQ) and equipment characterization across key aseptic manufacturing systems. The project scope includes E‑Beam tunnels, isolators, airlocks, and filling equipment. This role is critical to ensure timely and compliant execution of protocol‑based activities under a fast‑paced, GMP‑regulated environment. Key Responsibilities Execute and support characterization and PQ protocols across systems including E‑Beam, isolators, airlocks, and aseptic filling equipment . Coordinate execution timelines with internal stakeholders and functional owners under minimal supervision. Operate effectively in aseptic and controlled environments , adhering to strict cGMP standards and contamination control protocols. Handle materials , staging, and equipment preparation prior to protocol execution. Document execution activities in accordance with protocol instructions and data integrity expectations. Perform real‑time troubleshooting and elevate deviations or unexpected results promptly. Utilize systems such as LIMS , Kneat , and handle Batch Records (BI's) and documentation systems with accuracy and completeness. Participate in the scheduling, setup, and monitoring of equipment cycles, including decontamination and sterilization processes. Contribute to planning, execution tracking, and timely closure of executed studies and reports. Support multiple parallel workstreams with flexibility in scheduling and shift requirements. Minimum Qualifications Bachelor's degree in Science, Engineering, or a related technical field (Biology, Microbiology, Chemistry, or Engineering preferred). Minimum 1-3 years of hands‑on experience in validation, protocol execution, or aseptic operations in regulated environments. Demonstrated experience executing and troubleshooting PQ protocols and equipment characterizations . Familiarity with tools and systems such as Kneat , LIMS , Batch Record systems (BI's) , and data collection instruments. Availability to work rotating schedules , extended hours , and under high‑pressure timelines. Strong sense of initiative , with the ability to work independently , manage shifting priorities, and maintain a positive attitude under tight deadlines. Preferred Qualifications Prior experience in decontamination cycles , isolator testing, or E‑Beam tunnel operations. Comfortable navigating fast‑paced project environments with minimal supervision. Excellent problem‑solving , interpersonal, and communication skills. Weil Group is proud to be an Equal Employment Opportunity Employer. #J-18808-Ljbffr Remote Jobs