Validation Engineer

Fresenius Kabi USA, LLC; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health benefits: medical, prescription

Paid vacation/holiday/personal days

Job summary

Fresenius Kabi USA, LLC seeks a validation professional in Wilson, NC to provide technical support for equipment/system initial validation and requalification, ensuring cGMP compliance. The role involves report writing, data analysis, and working with cross-functional teams to improve plant systems.

The candidate will handle calibration, qualification studies, and deviations, with weekend/off-shift hours possible. Strong documentation and regulatory familiarity are required for success.

Qualifications

• Must understand cGMP practices and regulatory requirements.
• Experience entering controlled areas (Grade D/B/C) and training.
• Ability to write reports clearly and record data accurately.
• Basic understanding of statistical analysis.
• Weekends and off-shift hours may be required.

Responsibilities

• Schedules and executes equipment commissioning, qualification, and requalification per SOPs; coordinates testing and evaluates results.
• Executes validation studies including protocol prep, scheduling, execution, and final reports; presents results to regulators when needed.
• Programs and operates department instruments (e.g., data loggers) for chamber qualifications.
• Participates in improvements to validation programs to stay current with cGMPs.
• Part of teams to specify, install, validate, troubleshoot, and maintain systems.
• Conducts deviations and investigates root causes to define corrective/preventive actions.

Skills

cGMP knowledge

Report writing

Data analysis

Validation experience

Tools

Dataloggers

Job description

Job Summary

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification's. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (Grade D, C and up to B/ A). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Schedules and executes equipment commissioning, qualification, and requalification's per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Analyzes data, composes a final report and circulates for approval.
• Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation. Participates in presentation of results to Regulatory Agency when necessary.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Participates 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).

Salary Range: $60,966 - $85,694

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.

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.