Validation Engineer - cGMP Compliance & Data Reporting

Fresenius SE & Co. KGaA; North Carolina; On-site; USD 60,966 - 85,694; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation and personal days

Employee assistance program

Health benefits including medical, prescription, dental, and vision

Job summary

Fresenius SE & Co. KGaA is hiring for a position focused on providing technical support for equipment/system validation and requalification. This role entails scheduling and executing equipment commissioning, conducting validation studies, and maintaining compliance with cGMPs. Ideal candidates will possess strong report writing abilities and a basic understanding of statistical analysis. The salary range is $60,966 - $85,694, with a comprehensive benefits package, including a 401(k), health benefits, and paid time off.

Qualifications

• Comprehensive understanding of cGMPs required.
• Ability to write reports clearly and accurately.
• Basic understanding of statistical analysis is required.

Responsibilities

• Schedules and executes equipment commissioning and qualification.
• Executes equipment validation studies including protocol preparation.
• Programs and operates department analytical instruments.
• Conducts validation deviations and participates in investigations.

Skills

Technical support

cGMP understanding

Statistical analysis

Report writing

Tools

Temperature/humidity dataloggers

Job description

Fresenius SE & Co. KGaA is hiring for a position focused on providing technical support for equipment/system validation and requalification. This role entails scheduling and executing equipment commissioning, conducting validation studies, and maintaining compliance with cGMPs. Ideal candidates will possess strong report writing abilities and a basic understanding of statistical analysis. The salary range is $60,966 - $85,694, with a comprehensive benefits package, including a 401(k), health benefits, and paid time off.