Validation Engineer

301044 Fresenius Kabi USA, LLC; Kansas; On-site; USD 60,966 - 85,694; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday, and personal days

Employee assistance program

Medical, prescription drug, dental, and vision coverage

Life insurance and disability coverage

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a professional to provide technical support for equipment/system validation and requalification. The role requires a comprehensive understanding of cGMPs and the ability to write precise reports. Candidates should be prepared to work weekends and off-shift hours.

You will schedule and execute equipment qualifications, analyze data, and operate department analytical instruments. A certification to enter controlled areas is essential, alongside strong analytical and reporting skills.

The position offers a salary range of $60,966 - $85,694 and various employee benefits including a 401(k) plan and medical coverage.

Qualifications

• Comprehensive understanding of cGMPs.
• Certification to enter Controlled Areas (Grade D, C, up to B/A).
• Ability to work weekends and off-shift hours as required.

Responsibilities

• Schedule and execute equipment commissioning, qualification, and requalification.
• Analyze data and compose final reports.
• Program and operate analytical instruments for qualifications.
• Conduct validation deviations and participate in investigations.

Skills

Understanding of cGMPs

Ability to write reports

Statistical analysis skills

Attention to detail

Basic recording skills

Job description

Job Summary

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. The individual participates in equipment improvement teams charged with enhancing the compliance and performance of plant systems while considering regulatory requirements for change control. A comprehensive understanding of cGMPs and certification to enter Controlled Areas of the plant (Grade D, C up to B/A) are required. The ability to write clear, concise, accurate reports, record data, and basic statistical analysis skills are also necessary. Weekends and off-shift hours are periodically required.

Responsibilities

• Schedule and execute equipment commissioning, qualification, and requalification per Standard Operating Procedures (SOPs).
• Coordinate and communicate testing with affected functional groups and evaluate test results.
• Analyze data, compose final reports, and circulate for approval.
• Execute equipment validation studies, including protocol preparation, scheduling, execution, and final report preparation.
• Present results to Regulatory Agency when necessary.
• Program and operate department analytical instruments (e.g., temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (including lyophilizers, warehouses, sterilizers, incubators, etc.).
• Participate in developments/improvements to validation programs to remain current with cGMPs and industry standards.
• Participate in teams that specify, install, validate, troubleshoot, and maintain systems and equipment.
• Conduct validation deviations and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).

Qualifications

• Comprehensive understanding of cGMPs.
• Certification to enter Controlled Areas (Grade D, C, up to B/A).
• Ability to write clear, concise, accurate reports.
• Basic understanding of statistical analysis.
• Attention to detail and strong data recording skills.
• Ability to work weekends and off-shift hours as required.

Salary & Benefits

Salary Range: $60,966 - $85,694. Final pay determination will depend on experience, education, knowledge, skills, and abilities.

• 401(k) plan with company contributions
• Paid vacation, holiday, and personal days
• Employee assistance program
• Medical, prescription drug, dental, and vision coverage
• Life insurance and disability coverage
• Wellness program

Equal Opportunity

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.

Employment is at‑will; either party may terminate the employment relationship at any time in accordance with applicable federal and state laws.