Engineer - Validation and Testing

GEA Group; Janesville, Northern (WI, KY); On-site; USD 90,000 - 120,000; Full time

Job summary

GEA Group is seeking a Project Engineer with strong pharmaceutical validation experience to lead multi-project delivery, from design support to FAT/SAT execution. You will coordinate mechanical and electrical checklists, review protocol packages, and ensure on-time qualification across sites.

The role demands hands-on testing, documentation, and travel as needed to support installation and on-site qualification activities.

Qualifications

• Minimum 5–6 years of experience in Validation & Testing within the pharmaceutical industry.
• Broad knowledge of Pharma Formulation processes/product lines – Compression machines.
• Experience with qualification documentation packages, FAT/SAT processes.

Responsibilities

• Prepare & review mechanical and electrical checklists for machines.
• Prepare & review assembly protocols.
• Review qualification documentation package.
• Prepare FAT and SAT documents.
• Mechanical verification before FAT; execute FAT protocol.
• Perform machine validation & testing per protocol; placebo trials.

Skills

Validation & Testing

Pharma processes

Project engineering

Quality assurance

Education

Bachelor's degree in Engineering

Job description

Free day to volunteer

About the position

The GEA Group is one of the largest system providers globally for food, pharma and energy processes with about EUR 5.5 billion revenue in 2025 with its headquarters in Duesseldorf-Germany.GEA Pharma Systems is part of the GEA Group and is dedicated to innovation and thereby providing durable quality through its well established brands: Aeromatic-Fielder™ and Collette™ - batch and continuous granulation, drying, pelletizing and coating; Buck® & Buck Systems™ - containment interface and contained materials handling; Courtoy™ – tablet compression ( ORAL SOLID DOSAGE) “; GEA Pharma Systems’ activities include partnering with customers to develop new products and enhance clinical effectiveness; the supply of R&D-scale and stand-alone production equipment; and the installation of complete integrated production linesWhat are we looking for? A project engineer capable to engineer, design, schedule, coordinate and monitor the assigned multiple engineering projects. And whose responsibility lies in delivery and execution of project complying to quality, cost, schedule.

Your responsibilities and tasks

• Preparation & review of mechanical and electrical check list of machines.
• Preparation & review of Assembly protocols
• Review of qualification documentation package
• Preparation of FAT document
• Preparation of SAT document.
• Mechanical verification of machines as per protocol before FAT.
• Execution of FAT protocol during FAT
• Perform the machine Validation & Testing as per protocol.
• Execute and perform the Placebo trials on machine.
• Calibration of machine and peripherals required to calibrate the machine
• Compilation & verification of Test Certificates of individual parts of machine.
• Preparation of certification package
• Support to site engineering team during installation and qualification on site
• Willing to travel on site, if required.

Your profile and qualifications

Qualifications

Experience:

• Minimum 5-6 Years of experience in Validation & Testing role with pharmaceutical industry.

Desirable to have broad knowledge of Pharma Formulation processes/product lines – Compression machine

About GEA

GEA is one of the largest suppliers for the food and beverage processing industry and a wide range of other process industries. Approximately 18,000 employees in more than 60 countries contribute significantly to GEA’s success – come and join them! We offer interesting and challenging tasks, a positive working environment in international teams and opportunities for personal development and growth in a global company.

GEA is an equal opportunity employer. Applicants will therefore receive consideration for employment without regard to age, sex, race, color, religion, world view, national origin, genetics, disability, gender identity, marital status, sexual orientation, veteran status or any other protected characteristic required by applicable law. Applicants with disabilities are welcome and will be given special consideration if they are equally qualified.

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