Validation Engineer

RXinsider LTD.; Melrose Park (IL); On-site; USD 65,000 - 80,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation/holidays/personal days

Health, dental and vision coverage

Employee assistance program

Life insurance & disability

Job summary

Fresenius Kabi is seeking an on-site, full-time professional to support validation and qualification activities across plant systems. The role requires coordination of testing with multiple functional groups and producing clear final reports, with emphasis on cGMP compliance.

The candidate should have a bachelor’s degree in science or engineering and at least one year in a cGMP setting, with strong data analysis and documentation skills. Weekend/on-call hours may be required.

Qualifications

• Bachelor’s degree in a Science or Engineering field of study required.
• Minimum of one year relevant work experience in a cGMP regulated industry.
• Experience generating reports, deviations or other technical documents.
• Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
• Analytical datalogger programming, operating, troubleshooting, data-collecting preferred.
• PC literate with Word, Excel, PowerPoint, Project, Access competency
• Knowledge of cGMPs, industry guidance, and aseptic techniques
• Understanding of statistical analysis tools and methods.
• Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
• Knowledge of cGMP Cleaning Validation requirements and techniques
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools & techniques

Responsibilities

• Schedules and executes equipment requalifications per SOPs and coordinates testing with affected groups.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) and presents results to regulatory agencies when necessary.
• Programs and operates department analytical instruments to perform controlled chamber qualifications.
• Develops/improves validation programs to remain current with cGMPs and industry standards.
• Schedules and executes HEPA Filter and Critical Area testing per SOP and records results.
• Represents Technical Services in teams to specify, install, validate and maintain systems and processes.
• All employees must ensure compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Skills

Data analysis

Report writing

Datalogger programming

QA processes

Analytical skills

MS Office

Education

Bachelor’s degree in Science or Engineering

Tools

Dataloggers

Smoke generators

Photometers

Velocity meters

Job description

Job Summary

Salary Range: $65,000 to $80,000

Final 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.

Responsibilities

THIS POSITION IS NOT A REMOTE CONTRACT POSITION. THIS IS AN ONSITE, FULL-TIME SALARIED ROLE.

THIS POSITION IS NOT ELIGIBLE FOR VISA SPONSORSHIP NOW OR IN THE FUTURE.

Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). 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.

Job Responsibilities:

• Schedules and executes equipment requalifications 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.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Schedules and executes HEPA Filter and Critical Area (Class 100) testing per SOP. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• 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.

Job Requirements:

• Bachelor’s degree in a Science or Engineering field of study required
• Minimum of one year relevant work experience in a cGMP regulated industry.
• Experience generating reports, deviations or other technical documents.
• Experience with Installation, Operational and Performance Qualification protocol generation and execution strongly preferred.
• Analytical datalogger programming, operating, troubleshooting, data-collecting preferred.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
• Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques
• Understanding of statistical analysis tools and methods.
• Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
• Knowledge of cGMP Cleaning Validation requirements and techniques
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools & 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 Information

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