Validation Engineer

Fresenius Kabi USA; North Carolina; On-site; USD 60,966 - 85,694; Full time

Benefits offered by this job

401(k) with company contribution

Paid vacation, holiday and personal days

Health benefits: medical, dental, vision

Job summary

Fresenius Kabi USA is looking for a qualified individual to provide technical support for equipment/system validation in North Carolina. The role involves scheduling validations, writing reports, and operating analytical instruments, all while ensuring compliance with cGMP regulations. The salary range is competitive, and the benefits package includes health coverage, 401(k) contributions, and paid time off, ensuring a supportive work environment.

Qualifications

• Comprehensive understanding of cGMPs.
• Ability to write clear, concise, and accurate reports.
• Basic understanding of statistical analysis.

Responsibilities

• Schedule and execute equipment commissioning and qualification.
• Prepare and execute equipment validation studies.
• Operate analytical instruments for chamber qualifications.
• Participate in validation program improvements.
• Conduct validation deviations investigations.

Skills

cGMP understanding

Statistical analysis

Technical writing

Tools

Temperature/humidity dataloggers

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. 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 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, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, 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.