Quality Engineer

Position Summary

The cGMP Quality Engineer is accountable for ensuring that radiopharmaceutical manufacturing processes, equipment, and facilities operate in sustained compliance with cGMP, regulatory requirements, and internal quality standards. This role provides quality oversight and governance for process validation, equipment qualification, and manufacturing operations, ensuring that validated and qualified states are properly documented, maintained, and defended. Working closely with Manufacturing, MSAT, and Quality Assurance, the Quality Engineer serves as the quality authority embedded in technical operations, enabling compliant execution while maintaining inspection readiness.

Key Responsibilities

• Lead and own deviation investigations, root cause analysis, and the development and effectiveness of corrective and preventive actions (CAPA).
• Provide quality oversight for process validation, equipment qualification, aseptic processing, and cleanroom operations, ensuring adherence to approved protocols and regulatory expectations.
• Support site readiness activities including facility and cleanroom qualification, process startup, and introduction of new or modified manufacturing processes from a quality perspective.
• Review and approve GMP documentation, including protocols, reports, procedures, and technical change records, ensuring data integrity and compliance.
• Support internal, client, and regulatory audits and contribute quality input to regulatory submissions.
• Drive continuous improvement initiatives focused on compliance robustness, inspection readiness, and right-first-time manufacturing.

Qualifications & Requirements

• Bachelor’s degree in engineering (e.g., Chemical, Biomedical, Mechanical, Electrical), Chemistry, Life Sciences, or equivalent, or related field.
• A minimum of 6 years of experience in a Quality Engineering or Quality Assurance role within a regulated industry, preferably medical devices or pharmaceuticals.
• Experience with radiopharmaceuticals is highly desirable.
• Strong knowledge of cGMP regulations and pharmaceutical quality systems (e.g., FDA 21 CFR Parts 210/211, 820, Part 11 and Annex 1).
• Familiarity with GxP, compliance and phase-appropriate validation requirements.
• Experience with risk management tools and methodologies (e.g., FMEA, risk assessments, hazard analysis).
• Proficiency in root cause analysis, statistical analysis, and other structured problem-solving methods.
• Knowledge of validation and qualification techniques for processes, equipment, utilities, software, and cleanrooms.
• Familiarity with radiation safety principles (e.g., ALARA) is preferred.