Quality Assurance Validation

The QA Engineer – Validations provides quality oversight for validation lifecycle activities supporting sterile drug product manufacturing, with a strong focus on fill–finish operations. This role ensures that equipment, utilities, computerized systems, and aseptic processes used in formulation, filling, lyophilization, and finishing remain in a validated and compliant state. The ideal candidate brings deep understanding of aseptic processing, risk‑based validation, and the unique requirements of fill–finish environments.

Key Responsibilities

Validation Quality Oversight

• Review and approve validation documentation (URS, risk assessments, IQ/OQ/PQ protocols and reports) for equipment and systems used in fill–finish operations, including formulation vessels, filling lines, isolators/RABS, lyophilizers, and inspection systems.
• Provide QA oversight for validation of clean utilities (WFI, clean steam, compressed gases) and controlled environments supporting aseptic filling.
• Ensure validation activities align with FDA, EMA, ICH, Annex 1, and industry best practices for sterile and fill–finish operations.
• Oversee computerized system validation (CSV) for automated filling, inspection, and packaging systems, ensuring compliance with data integrity and 21 CFR Part 11.

Fill–Finish Process Support

• Provide QA presence during critical fill–finish activities, including aseptic process simulations, line qualification, and equipment sterilization validation.
• Support validation of formulation processes, sterile filtration, container closure systems, and visual inspection technologies.
• Partner with Manufacturing, Engineering, and Validation teams to ensure fill–finish processes remain in a validated state throughout the product lifecycle.
• Review and approve batch records, sterilization cycles, and environmental monitoring data related to fill–finish operations.
• Lead or support investigations and CAPAs related to fill–finish equipment, aseptic processing, or validation failures.
• Assess validation impact for changes to filling equipment, components, formulations, or process parameters.
• Identify opportunities to optimize fill–finish validation strategies while maintaining compliance and product quality.
• Contribute to development and revision of SOPs, templates, and quality standards related to aseptic processing and fill–finish validation.

Qualifications Required

• Bachelor’s degree in engineering, Life Sciences, or related field.
• 3 years of experience in validation or QA within a GMP sterile manufacturing or fill–finish environment.
• Strong understanding of aseptic processing, contamination control, and fill–finish operations.
• Working knowledge of validation lifecycle principles, risk management, and data integrity requirements.
• Familiarity with regulatory expectations including FDA, EMA, ICH Q7–Q10, and Annex 1.
• Excellent communication, documentation, and cross‑functional collaboration skills.

Preferred

• Experience with isolator‑based filling, automated inspection systems, or lyophilization.
• Knowledge of container closure integrity testing (CCIT) and sterile filtration validation.
• CSV experience aligned with GAMP 5.
• Participation in regulatory inspections for sterile or fill–finish operations.

This is an On site role (1 hour out of NYC, Commuting) Candidates must be located in the Area or Commute on a daily basis. No Remote or Hybrid Schedule.