Validation Engineer

Fresenius Kabi•Wilson, NC

1d•Onsite

About The Position

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.

Requirements

Comprehensive understanding of cGMPs
Ability to write reports clearly, concisely and accurately
Accurately record data
Basic understanding of statistical analysis
Ability to become certified to enter Controlled Areas of the plant (Grade D, C and up to B/ A)

Nice To Haves

Participates in presentation of results to Regulatory Agency when necessary.

Responsibilities

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).