Validation Engineer – cGMP Compliance & Data Reporting

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

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.