Validation Engineer (Computer Systems)

Fresenius Kabi; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation and holidays

Personal days

Employee assistance program

Health, dental, vision coverage

Job summary

Fresenius Kabi is seeking a Validation Engineer to specialize in computerized systems validation across MES (EBR), Historian (QMIB), LAB-X and related manufacturing applications. The role focuses on technical and documentation work with cross‑functional collaboration at site, regional, and global levels.

The candidate will develop qualification protocols, perform studies, prepare final reports, and contribute to regulatory interactions.

Qualifications

• Bachelor’s Degree in a Science or Engineering field.
• Minimum of one year of related experience in a cGMP facility.
• Experience with FDA regulations, medical, drug and device products.

Responsibilities

• Schedule and execute computer system qualifications per SOPs.
• Assemble final reports and circulate for approval.
• Develop and update validation documents (URS, FDS, DS, FMEAs).
• Provide technical support for investigations and change controls.
• Ensure compliance with cGMPs and industry standards.

Skills

cGMP knowledge

Analytical skills

Technical writing

Verbal communication

Education

B.S. in Science or Engineering

Tools

MES (EBR)

Historian (QMIB)

OEE concepts

Job description

Job SummarySalary: $65,000 to $80,000Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.ResponsibilitiesThe 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.Job 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 standardsRepresents 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 requirementsAuthors 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 disciplinesAdditional 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 responsibilitiesJob Requirements:Bachelor’s Degree in a Science or Engineering field of studyMinimum 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 experienceKnowledge and understanding of cGMPs, industry guidance, and aseptic techniquesExcellent 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) competencyGood 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 Company’s primary business language is English. 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.Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.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.