Validation Engineer - Pharmaceutical Manufacturing

Job Description

Validation Engineer – Pharmaceutical Manufacturing
Location: Southeast Wisconsin Onsite

Contract: 6+ Month Contract (Extensions Likely)

Automated Systems, Inc. is seeking a skilled Validation Engineer to support one of our premier pharmaceutical manufacturing clients in the Southeast Wisconsin region. This role is ideal for a validation professional who thrives in a fast-paced, highly regulated environment and is passionate about ensuring equipment, processes, and facilities meet the highest cGMP standards. As a key contributor to the validation team, you will lead the development, execution, and analysis of validation projects and serve as a cross-functional liaison to ensure seamless project alignment and execution.

Key Responsibilities:

• Lead the development, execution, and analysis of validation projects ensuring full cGMP compliance.
• Generate and execute IQ/OQ/PQ protocols and author comprehensive summary reports.
• Collaborate with internal and external teams to define project goals, priorities, structure, and optimal validation strategies.
• Author and execute IQ/OQ/PQ protocols for packaging equipment and operations.
• Draft and maintain change controls, SOPs, and work instructions.
• Provide technical guidance on change controls, CAPAs, and deviations.
• Design and perform process and cleaning validation activities in accordance with site and industry standards.
• Support product changeovers, troubleshooting efforts, and continuous improvement initiatives.

Required Education & Experience:

• Bachelor’s degree in pharmacy, Engineering, or a related Science discipline.
• 3+ years of life sciences engineering experience.
• 3+ years of hands-on validation experience.
• Proficiency working with packaging equipment such as:
  Bottle fillers, blister fillers, cappers, case packers, labelers, barcoding systems, and Uhlmann thermoformers.
• Strong understanding of cGMP Cleaning, Process, and Product Validation requirements.
• Experience in FDA/cGMP-regulated environments is required.
• Exceptional communication, collaboration, and presentation abilities.
• Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.