Validation Engineer – cGMP Equipment Qualification

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

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.