We are seeking a highly motivated Performance Qualification (PQ) Engineer to support our pharmaceutical manufacturing team. The successful candidate will be responsible for ensuring the qualification and validation of critical equipment, such as parts washers, autoclaves, and thermal mapping systems, to maintain compliance with industry regulations and deliver high-quality pharmaceutical products.
Key Responsibilities:
1. Perform Performance Qualification (PQ) activities for pharmaceutical manufacturing equipment, including parts washers, autoclaves, and thermal mapping systems.
2. Develop, execute, and review qualification protocols (IQ, OQ, PQ) in accordance with cGMP and regulatory standards, ensuring seamless implementation.
3. Analyze and interpret validation data to ensure adherence to industry best practices and regulatory requirements.
4. Support thermal mapping studies for controlled storage environments, guaranteeing temperature and humidity consistency throughout.
5. Collaborate closely with cross-functional teams, including Quality Assurance, Engineering, and Manufacturing, to optimize equipment performance and efficiency.
6. Maintain detailed documentation and reports for audits and regulatory inspections, providing transparency and accountability.
7. Troubleshoot and resolve validation issues promptly, minimizing downtime and ensuring business continuity.
Requirements:
1. Bachelor's degree in Engineering, Life Sciences, or a related field, with a strong foundation in scientific principles.
2. Prior experience in equipment qualification and validation within a pharmaceutical or regulated manufacturing environment is essential.
3. A thorough understanding of cGMP, FDA, and EU regulatory requirements is mandatory, ensuring compliance and adherence.