Sr. Validation Engineer

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

Job Summary

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also coordinate HEPA filter integrity/velocity testing and critical area airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant. Provides direction through direct or indirect supervision to validation team members and contractors as necessary.

Salary Range: $73,614 - $103,528

Position is eligible to participate in a bonus plan with a target of 6% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Schedules and participates in equipment requalifications per Standard Operating Procedures (SOPs).Coordinates and communicates all testing with affected functional groups, where applicable, and evaluates test results.Approves final report and/ or assembles and circulates for approval when necessary.
• Executes validation studies, or acts as a Project Manager and/ or Technical Reviewer, for equipment to include protocol preparation, scheduling, protocol execution, and final report preparation.
• Presents results to Regulatory Agency when necessary.
• Programs, leads and/ or operates department instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Schedules and executes, when applicable, HEPA Filter and critical area testing per SOP, and airflow pattern testing. Programs, leads, and/or operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
• Represents Validation department in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.