Validation Engineer

Fresenius Kabi USA • 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 be certified to enter Controlled Areas of the plant (Grade D, C and up to B/ A)

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).

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• 401K with company contribution
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees