Sr. Validation Engineer (Smoke Study Validation Services)

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401K with company contributions

Medical, dental and vision coverage

Life insurance

Disability benefits

Wellness program

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL, is seeking a Validation Specialist to plan, execute, and document IQ/OQ/PQ activities for new and existing pharmaceutical equipment and facilities. You will lead cross-functional teams to ensure compliance with cGMPs and ISO standards while improving plant systems for efficiency and reliability.

The role requires strong technical writing, project management, and analytical skills, with weekends or off-shift hours possible.

Qualifications

• Bachelor degree in Engineering or a Scientific Field required.
• Minimum of 3 years relevant experience in a cGMP facility; pharmaceutical industry experience preferred.
• Proficient in generating reports, technical writing/reviewing skills and other technical documents required.
• Knowledge and understanding of cGMPs, industry guidance and aseptic techniques needed.

Responsibilities

• Independently plan, perform and document validation activities (IQ, OQ, PQ) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing environment.
• Create validation schedules, coordinate execution efforts with contractors, production operators, manufacturing engineers and quality assurance personnel.
• Track and communicate progress of work against milestones.
• Compose validation plans, protocols, traceability matrices, risk assessments and final report summaries.
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Represents Validation in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Conduct deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Responsible for maintaining and improving the ISO 50001 energy management system.
• Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.
• Monitor and analyze energy consumption.

Skills

Technical writing

Validation planning

Project management

Statistical analysis

Cross-functional teamwork

Education

Bachelor degree in Engineering or a Scientific Field

Tools

Microsoft Office

Job description

Job Summary

Salary Range: $80,000 to $100,000 This position is eligible to participate in a bonus plan with a target of 6% of the base salary. 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 initial equipment/facility/utility qualifications and equipment/facility/utility 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. Individual must display a solid technical understanding of validation principles. The individual must be able to lead validation projects showing proficiency in project and time management skills. 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.

KEY Responsibilities

• Create and maintain detailed AFV protocols in line with SOPs, GMP, GDP, ISO 14644-1/2, EU Annex 1, and ASTM E2500 requirements
• Plan and conduct static and dynamic smoke/fog studies in GMP cleanrooms, RABS, isolators, filling lines, and Grade A/B environments
• Set up, qualify, and maintain smoke/fog generation systems, lighting, and video recording equipment
• Record and compile raw video footage, produce final video reports, and present findings to cross-functional teams
• Identify airflow issues (turbulence, dead spots, reverse flows), lead deviations, risk assessments, and CAPAs
• Work with engineering, QA, operations, and manufacturing teams to define scope, resolve issues, and support regulatory inspection readiness
• Handle administrative tasks, generate marketing materials for AFV services, and update SOPs
• Handle administrative tasks, generate marketing materials for AFV services, and update SOPs

Job Responsibilities (including, but not limited to):

• Independently plan, perform and document validation activities (IQ, OQ, PQ) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing environment.
• Create validation schedules, coordinate execution efforts with contractors, production operators, manufacturing engineers and quality assurance personnel.
• Track and communicate progress of work against milestones.
• Compose validation plans, protocols, traceability matrices, risk assessments and final report summaries.
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Represents Validation in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Conduct and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Responsible for maintaining and constant improvement of the ISO 50001 energy management system.
• Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.
• Monitor and analyze energy consumption.
• 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 degree in Engineering or a Scientific Field required
• Minimum of 3 years relevant experience in a cGMP facility; pharmaceutical industry experience preferred
• Proficient in generating reports, technical writing/reviewing skills and other technical documents required
• Knowledge and understanding of cGMPs, industry guidance and aseptic techniques needed
• PC literate with Microsoft Office proficiency

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 atwill, 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.