Quality Assurance Engineer – Lyophilization Systems

We are seeking a Quality Assurance Engineer with experience in lyophilization systems to ensure compliance, validation, and quality excellence across equipment and processes. The role will involve working across the equipment lifecycle, including exposure to Design Qualification (DQ) and Factory Acceptance Testing (FAT), along with core QA responsibilities.

Key Responsibilities:

• Support preparation and review of qualification documents including DQ, IQ, OQ, and PQ
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities
• Ensure compliance with GMP, GLP, and regulatory requirements (FDA, WHO, EU)
• Review batch records, SOPs, and validation documentation
• Handle deviations, CAPA, and change control processes
• Collaborate with Engineering, Production, and Vendors for equipment qualification and process improvement
• Ensure traceability across URS, DQ, FAT, SAT, and validation lifecycle
• Support audits and regulatory inspections
• Maintain documentation integrity and quality standards

 

Required Qualifications:

• Bachelor’s/Master’s in Pharmacy, Chemical Engineering, Biotechnology, or related field
• 3–7 years of experience in QA within pharmaceutical/biotech manufacturing
• Experience with lyophilization (freeze-drying) systems
• Working knowledge of equipment qualification and validation processes

Key Skills:

• Understanding of validation lifecycle (URS to PQ)
• Exposure to DQ documentation and FAT participation
• Strong knowledge of GMP and quality systems
• Attention to detail and documentation excellence
• Good cross-functional coordination and communication skills