CQV & Packaging Engineer

Responsibilities

• Develop and execute CQV protocols, reports, and risk assessments in accordance with client procedures and cGMP, FDA, EMA, and other regulatory guidelines.
• Coordinate validation activities with Manufacturing and QA to ensure proper execution.
• Investigate and support the resolution of protocol deviations and nonconformities.
• Support change control activities related to system and equipment modifications.
• Write and maintain SOPs related to system and equipment operation and maintenance.
• Ensure documentation meets internal quality standards and audit readiness.

Requirements

• Be an effective and independent, seasoned lead contributor that requires minimal to no supervision and delivers results.
• Bachelor’s degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field.
• Minimum 7+ years of experience in the Biotechnology or Pharmaceutical industries
• Minimum 3+ years of experience in Packaging Validation including filling and capping process, isolators, drop test, stress test and packaging systems.
• Strong technical writing and protocol/report development skills.
• Ability to interpret complex data and resolve validation issues.
• Effective english-native communication and cross-functional collaboration skills.
• Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Kneat, Veeva, etc., a plus).