Automated Technology (Phil.) Inc. - ATEC · 1 month ago
Validation Engineer – Pharmaceutical Manufacturing
Kenosha, WI
Full-time
Onsite
Mid Level
$38/hr - $50/hr
3+ years expAutomated Systems, Inc. is seeking a skilled Validation Engineer to support one of their premier pharmaceutical manufacturing clients in the Southeast Wisconsin region. The role involves leading validation projects and ensuring compliance with cGMP standards, while collaborating with various teams to achieve project goals.
IndustrialIndustrial DesignManufacturingSemiconductor
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
Qualification
Required
Bachelor's degree in 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)
Benefits
Dental insurance
Health insurance
Paid time off
Referral program
Company
Automated Technology (Phil.) Inc. - ATEC
ATEC is driven by our vision of being the strategic partner to our customers, focusing on customized service and offering a consistently first-rate and dynamic range of technical capabilities.
501-1000 employees
H1B Sponsorship
Automated Technology (Phil.) Inc. - ATEC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase