VALIDATION ENGINEER

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

Benefits offered by this job

401(k) plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Job summary

Fresenius Kabi in Wilson, NC seeks a technical specialist in equipment validation to support initial qualification and requalification per cGMPs. You will join cross-functional teams, write clear reports, and help ensure compliant, high-performing plant systems.

Some weekends/off-shift hours are required. The role involves conducting validation studies, SOPs, data analysis, and participation in change-control processes.

Qualifications

• Must understand cGMPs and regulatory requirements.
• Ability to write reports clearly and accurately.
• Experience with data analysis and statistical concepts.

Responsibilities

• Drafts protocols and executes equipment commissioning, qualification, and requalification per SOPs.
• Executes validation studies including protocol preparation, scheduling, execution, and final report.
• Programs and operates analytical instruments for controlled temperature/humidity chamber qualifications.
• Participates in improvements to validation programs to stay current with cGMPs.
• Participates in teams to specify, install, validate, troubleshoot and maintain systems.
• Conducts validation deviations and investigates root causes to define corrective actions.

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.

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 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

• Drafts protocols 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).

Additional Information

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

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.