Validation Engineer (Computer Systems)

Fresenius Kabi USA • Melrose Park, IL

1d • $65,000 - $80,000

About The Position

The Validation Engineer is specialized in computerized systems validation and knowledgeable in MES (EBR), historian(QMIB), LAB -X and other manufacturing applications. Provides technical & documentation support for manufacturing process and associated computer systems. Also compliance knowledge on various aseptic manufacturing processes (sterilization, isolator technology, clean rooms, computerized systems, etc). Uses his/her expertise to maintain industry standards within the company.
The focus of the Validation Engineer is on technical and documentation aspects of the department and typically does not have direct report. The Validation Engineer must have excellent verbal and written communication skills as this position interacts directly with multiple departments at the site, regional and global levels.

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.
• The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Responsibilities

• 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 for 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, test scripts.
• Develops and updates full life cycle documents includes, URS, FDS, DS, risk assessments, impact assessment, 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. Generates innovative solutions to solve difficult problems that may impact multiple disciplines
• 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

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
• wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level