Automated Technology (Phil.) Inc. - ATEC · 16 hours ago
Validation Engineer
Chicago, IL
Full-time
Onsite
Mid Level
$38/hr - $55/hr
3+ years expAutomated Systems, Inc. (ASI) is seeking an experienced Validation Engineer to join the team at one of their pharmaceutical manufacturing clients located in the Greater Chicagoland Area. In this high-impact role, you’ll lead full-cycle validation efforts across equipment, processes, and facilities, ensuring compliance with cGMP and regulatory standards while supporting critical manufacturing operations.
Contact ManagementManufacturingSemiconductor
Responsibilities
Support, plan, execute, and document equipment qualification and validation activities, including IQ/OQ/PQ
Develop and review protocols, reports, and deviations in accordance with cGMP and internal SOPs
Author and execute IQ/OQ/PQ Protocols packaging equipment and operations
Collaborate with cross-functional teams including Quality, Engineering, and Operations
Identify deviations and trends, recommend corrective actions, and ensure proper documentation
Author change controls, SOPs, and work instructions
Provide technical assistance to change controls/CAPA’s, and deviations
Ensure compliance with regulatory standards (FDA, ISO, etc.) and company policies
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
Minimum of 3 years' experience in equipment qualification and validation activities, including IQ/OQ/PQ, and equipment validation in a regulated environment
Experience with pharmaceutical, biotech, or medical device manufacturing
Relevant experience of understanding the validation and pharma guidelines
Strong understanding of cGMP, FDA, and ISO requirements
Understanding of statistical analysis tools and methods
Direct experience with writing and executing validation protocols
Excellent technical writing and documentation skills
Proficient in data analysis and technical reports
Ability to work independently and cross-functionally within a fast-paced GMP manufacturing environment
Excellent communication and organizational skills
Strong analytical and problem-solving skills
Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment
Proficient in Word, Excel, and PowerPoint
Benefits
Dental insurance
Flexible spending account
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