Sr. Validation Engineer (Smoke Study Validation Services)

Fresenius SE & Co. KGaA; Melrose Park, Northern (IL, KY); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) contributions

Paid time off

Health benefits

Employee Assistance Program

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a Validation Engineer for an onsite, full-time role in a cGMP pharmaceutical manufacturing environment. The candidate will plan, perform and document validation activities for equipment, facilities and utilities, and coordinate with multi-disciplinary teams to ensure compliance and project success.

The role requires a Bachelor degree in Engineering or a scientific field and at least 3 years in a cGMP facility; strong report writing, GMP knowledge and

Qualifications

• Bachelor degree in Engineering or a scientific field required.
• Minimum 3 years of experience in a cGMP facility; pharmaceutical experience preferred.
• Proficient in generating reports and technical writing.
• Knowledge of cGMPs, industry guidance, and aseptic techniques.

Responsibilities

• Plan, perform and document validation activities for equipment, facilities and utilities in a pharmaceutical manufacturing environment.
• Create validation schedules and coordinate execution with contractors, production operators, manufacturing engineers and QA 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 to remain current with cGMPs and industry standards.
• Represents Validation in teams to specify, install, validate, troubleshoot and maintain systems, equipment and processes.

Education

Bachelor degree in Engineering or a scientific field

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 andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.