LL01-251114 - CQV Specialist Media Fill (Aseptic Process)

Validation & Engineering Group • Juncos, PR

36d

About The Position

The Media Fill CQV Specialist is responsible for planning, executing, and documenting aseptic process simulations to ensure sterility assurance across filling operations. This role supports validation of operational practices, interventions, and equipment configurations in compliance with FDA, EMA, and Annex 1 requirements.

Requirements

• Bachelors in Life Sciences, Microbiology, Engineering, or related discipline.
• 5+ years of experience in aseptic operations, process validation, or APQ/CQV.
• Strong understanding of aseptic techniques, cleanroom behavior, and contamination control.
• Experience writing and executing validation protocols (PQ, APS).
• Ability to analyze results, perform root cause investigations, and justify decisions to QA and regulators.

Nice To Haves

• Experience in fill-finish or parenteral manufacturing.
• Knowledge of isolators, RABS, and automated filling systems.
• Familiarity with EM programs and ISO 14698.

Responsibilities

• Plan and execute Media Fill (Aseptic Process Simulation) studies in coordination with QA, Manufacturing, and Aseptic Operations.
• Verify proper execution of interventions, sampling plans, and line configurations.
• Ensure media fill setup aligns with aseptic processing requirements, including operator practices, equipment state, and environmental conditions.
• Monitor contamination control strategies and document all observations.
• Prepare protocols (APS Plans, PQ protocols), execute testing, and draft final reports.
• Manage deviations, CAPAs, investigations, and risk assessments associated with media fills.
• Support regulatory audit readiness and provide technical justification during inspections.
• Ensure compliance with FDA Aseptic Processing Guidance, EU Annex 1, and 21 CFR 210/211.
• Maintain data integrity and GMP documentation standards (ALCOA+).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Personal and Laundry Services
• Number of Employees: 101-250 employees