Senior Validation Engineer - cGMP Equipment Testing

Fresenius Kabi USA, LLC; Wilson (NC); On-site; USD 74,000 - 104,000; Full time

Job summary

Fresenius Kabi USA, LLC is seeking a validation professional responsible for initial validation and requalification of plant equipment and systems. The role includes coordinating HEPA filter integrity testing, critical area airflow testing, and leading validation teams while ensuring cGMP compliance.

The position offers a competitive salary, bonus plan with a target of 6% of base salary, substantial benefits, and opportunities to contribute to equipment improvements in a regulated manufacturing

Qualifications

• Comprehensive understanding of cGMPs and regulatory requirements.
• Certified to enter controlled areas of the plant.
• Experience leading validation teams and coordinating with contractors.

Responsibilities

• Schedules and participates in equipment requalifications per SOPs and coordinates testing with affected functional groups.
• Executes validation studies; acts as Project Manager and Technical Reviewer for equipment validation.
• Presents results to Regulatory Agency when necessary.
• Operates instruments for temperature/humidity chamber qualifications (e.g., lyophilizers, warehouses, sterilizers).
• Develops/improves validation programs to stay current with cGMPs and industry standards.
• Schedules and executes HEPA filter and critical area testing per SOP; operates test equipment and records results.
• Represents Validation department in teams to specify, install, validate, troubleshoot and maintain systems and equipment.
• Conducts validation deviations and participates in deviation investigations to identify root causes and corrective/preventative actions (CA/PA).
• Ensures compliance with company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Job description

Fresenius Kabi USA, LLC is seeking a validation professional responsible for initial validation and requalification of plant equipment and systems. The role includes coordinating HEPA filter integrity testing, critical area airflow testing, and leading validation teams while ensuring cGMP compliance.

The position offers a competitive salary, bonus plan with a target of 6% of base salary, substantial benefits, and opportunities to contribute to equipment improvements in a regulated manufacturing