Job Description

• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing processes, equipment, and systems.

• Validate and oversee the performance of IV solution and IV bag manufacturing processes.

• Conduct Computer System Validation (CSV) for automated systems and ensure compliance with industry standards and regulations.

• Validate filing equipment, ensuring accuracy and efficiency in the production process.

• Collaborate with cross-functional teams, including chemistry, automation, and manufacturing, to ensure validated systems meet all requirements.

• Maintain detailed validation documentation and reports in compliance with Good Manufacturing Practices (GMP).

• Support continuous improvement efforts to enhance process reliability and efficiency.

• Bachelor's degree in engineering, Chemistry, or a related field.

• Proven experience in validation processes in pharmaceutical, medical device, or related industries.

• Knowledge of IV solution and IV bag manufacturing processes.

• Strong experience with Computer System Validation (CSV) and automated manufacturing systems.

• Experience with equipment validation, particularly with filing equipment.

• Familiarity with GMP, FDA, and other regulatory requirements.

• Excellent analytical, problem-solving, and communication skills.

• Prior experience in automation, chemistry, and manufacturing environments.

• Experience in a highly regulated industry with a focus on quality and compliance.

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