Description:

Commissioning: Lead or support commissioning activities for cleanroom systems and equipment, ensuring proper installation and functionality according to design specifications.

Qualification and Validation: Develop and execute qualification and validation protocols for QC Lab Equipment (examples are HPLC, CTUs, Balances, BacT Alert, ViCell Blu), cleanroom systems including autoclaves, glassware washers, and clean utilities such as compressed air, steam, and water systems.

Documentation and Reporting: Maintain comprehensive documentation of commissioning, qualification, and validation activities. Generate protocols, execute tests, and prepare final reports ensuring compliance with regulatory requirements and company standards.

Troubleshooting and Optimization: Identify and resolve technical issues during commissioning and validation activities. Optimize system performance through troubleshooting, root cause analysis, and process improvements.

Compliance Assurance: Ensure all commissioning and validation activities adhere to regulatory requirements such as FDA, cGMP, and ISO standards. Stay abreast of regulatory updates and industry best practices to maintain compliance.

Requirements: 

• Bachelor’s degree in Engineering, Life Sciences, or related field. Advanced degree preferred.
• Proven experience in commissioning, qualification, and validation of QC Lab Equipment, cleanroom systems and equipment, in a biopharmaceutical or biotechnology environment.
• Strong understanding of regulatory requirements and guidelines including FDA, cGMP, ALCOA+, and ISO standards.
• Proficiency in developing and executing validation protocols, and protocols and documenting validation activities in a regulated environment and creating final protocol packages and final reports.
• Required technical expertise in QC Lab environments, cleanroom systems including autoclaves, glassware washers, clean utilities (compressed air, steam, water), HVAC, and steam systems.
• Analytical mindset with excellent problem-solving skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate across