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.

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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.

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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.

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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.**