LL01-250725 Sterility Assurance Specialist (IN)

Job Description

Job 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:

• Sterility Assurance Specialist

Position Summary:
The Sterility Assurance Specialist is responsible for developing, implementing, and maintaining robust sterility assurance strategies and systems to support aseptic manufacturing, terminal sterilization, and contamination control. The role ensures compliance with global regulatory requirements (FDA, EMA, ISO, etc.), Good Manufacturing Practices (GMP), and company quality standards.

Key Responsibilities:
• Develop and maintain the Contamination Control Strategy (CCS) in alignment with EU Annex 1, FDA Guidance, and industry best practices.
• Provide technical oversight for aseptic processing, cleanroom qualification, and sterilization processes (e.g., moist heat, dry heat, radiation, filtration).
• Lead and support media fill (aseptic process simulation) planning, execution, and evaluation.
• Review and approve environmental monitoring (EM) and cleanroom classification protocols and data trends.
• Serve as the subject matter expert (SME) during regulatory inspections and internal audits related to sterility assurance.
• Evaluate and recommend improvements in facility design, airflow patterns, and personnel/material flow for aseptic areas.
• Provide input into the design qualification and validation of sterilizers, cleanroom HVAC systems, isolators, RABS, and barrier technologies.
• Participate in deviation investigations, CAPAs, and risk assessments involving microbiological contamination or sterility failures.
• Author and maintain SOPs, risk assessments, protocols, and reports related to sterility assurance.
• Support training programs for aseptic technique, gowning, and microbiological control.
• Collaborate with Quality, Validation, Engineering, and Manufacturing to ensure a holistic approach to sterility assurance.

Required Qualifications:
• Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, Biotechnology, or related field.
• 5+ years of experience in a GMP-regulated environment, preferably in aseptic processing or microbiology QA/QC.
• In-depth knowledge of GMP, USP <71>, <85>, <1116>, EU Annex 1, ISO 14644, and PDA technical reports.
• Experience with cleanroom operations, aseptic technique, sterilization methods, and EM programs.
• Strong problem-solving, risk assessment, and technical writing skills.
• Excellent communication skills and ability to work cross-functionally.

Preferred Qualifications:
• Experience with isolator technology or advanced aseptic processing (e.g., closed RABS, automated filling lines).
• Knowledge of terminal sterilization validation, biological indicators, and sterility test validation.
• Familiarity with Lean/Six Sigma or Quality by Design (QbD) principles in sterility assurance.
• Prior participation in regulatory inspections (FDA, EMA, MHRA, etc.) as SME.