Validation Specialist

Weil Group Ver todas las vacantes

  • Juncos, PR
  • Permanente
  • Tiempo completo
  • Hace 24 días
Validation SpecialistPQ Focus (E-Beam, Isolators, Filling Equipment)Position OverviewWe 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 escalate 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.**

Weil Group