Validation Engineer

Job Summary

Responsible for providing technical support to operations in terms of equipment / system initial validation and equipment / system requalification's. 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's 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).

REQUIREMENTS

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 , andwellness program.

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.