Validation Engineer

• Schedules and executes computer system qualifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates the approval.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
• Participates in dry running the manufacturing system applications and develops the test scenarios, test environments, and test scripts.
• Develops and updates full life cycle documents including URS, FDS, DS, risk assessments, impact assessments, FMEAs, and test and qualification protocols.
• Develops / improves validation programs as needed to remain current with cGMPs and industry standards
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot, and maintain systems, equipment and processes.
• Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Authors validation master plans and validation project plans outlining qualification requirements
• Authors the documentation needed for MES (EBR), Historian (QMIB), manufacturing applications and infrastructure like industrial data center, etc.
• Provides technical support for investigations, Action Plans, Change Controls, and Risk Assessments as required
• Additional projects and tasks as assigned
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

• Bachelor's Degree in a Science or Engineering field of study
• Minimum of one year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
• Installation, Operational and Performance Qualification protocol generation and execution experience
• Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques
• Excellent technical writing and verbal communication skills. Experienced in negotiating.
• Understanding of MES(EBR), historian, oee, and other manufacturing applications.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
• Good communication skills and leadership skills.
• Good judgment and decision skills.
• Problem solving and multi-tasking.
• Project supervision and project management skills.
• Ability to work independently.
• Ability to adapt and handle change.
• Knowledge of cGMP Process and Product Validation requirements and techniques.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, 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.