Lead Smoke Study Validation Engineer – GMP/ISO Expert

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

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.