LL02-250725 Validation Specialist for Aseptic Process/Media Fill

Job DescriptionJob Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Specialist – Aseptic Process / Media Fill

Position Summary:
The Validation Specialist for Aseptic Processes and Media Fill is responsible for planning, executing, and documenting validation activities related to aseptic processing, with a specific focus on aseptic process simulations (APS/media fills). The role supports validation lifecycle management, ensuring compliance with regulatory requirements and company standards for sterile manufacturing.

Key Responsibilities:
• Lead the planning, coordination, execution, and reporting of Media Fills / Aseptic Process Simulations (APS) in compliance with FDA, EU Annex 1, and internal policies.
• Prepare and maintain media fill protocols, risk assessments, and summary reports in alignment with validation master plans.
• Support the qualification of cleanrooms, personnel, equipment, and processes used in aseptic manufacturing.
• Coordinate with Microbiology, QA, Manufacturing, and Engineering to ensure readiness for media fills, including line clearance, gowning qualifications, and personnel scheduling.
• Review and trend media fill data, EM results, and interventions to ensure process robustness and aseptic control.
• Support investigations and CAPAs related to media fill failures, aseptic interventions, or environmental deviations.
• Assist in the validation of sterilization processes, including steam, dry heat, filtration, and sanitization procedures.
• Participate in the development and execution of cleanroom qualification protocols, airflow visualizations (smoke studies), and process simulations.
• Support the creation, review, and approval of validation documentation, SOPs, and work instructions for aseptic processes.
• Act as SME during internal audits and regulatory inspections for aseptic validation activities.
• Collaborate in continued process verification (CPV) and ongoing qualification strategies.

Required Qualifications:
• Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or a related field.
• 5+ years of experience in validation, aseptic processing, or sterile manufacturing in a GMP-regulated environment.
• Strong understanding of FDA aseptic guidance, EU Annex 1, USP <71>, <797>, <1116>, and related validation guidelines.
• Demonstrated experience with media fill design, execution, and documentation.
• Strong attention to detail and experience with risk-based validation approaches.
• Excellent technical writing, organizational, and cross-functional collaboration skills.

Qualifications:
• Experience with isolator or RABS-based aseptic systems.
• Knowledge of visual inspection validation, filling line qualification, and cleanroom behavior qualification.
• Familiarity with VMPs, CQV (Commissioning, Qualification, Validation), and quality risk management (QRM) practices.
• Involvement in regulatory inspections (FDA, EMA, MHRA) as subject matter expert.