Automated Systems, Inc. (ASI) · 2 weeks ago
Validation Engineer – Pharmaceutical Manufacturing
Greater Chicago Area
Contract
Onsite
Mid Level
$38/hr - $55/hr
3+ years expAutomated Systems, Inc. is seeking a skilled Validation Engineer to support a global pharmaceutical manufacturing client located in the Greater Chicagoland Area. In this role, you will lead validation initiatives for equipment, processes, and facilities to ensure compliance with cGMP standards.
ConsultingInformation TechnologyLegalPharmaceuticalStaffing Agency
Responsibilities
Responsible for development, execution & analysis of validation projects to demonstrate facility cGMP compliance
Responsible for the generation and execution of IQ/OQ/PQ protocols and summary reports
Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure, and optimization of validation approaches
Author and execute IQ/OQ/PQ Protocols packaging equipment and operations
Author change controls, SOPs, and work instructions
Provide technical assistance to change controls/CAPA’s, and deviations
Design and execute process and cleaning validation studies meeting site and industry standards
Assist with product changeovers, troubleshooting investigations and continuous improvement initiatives
Collaborate with internal and external technical and management personnel to establish project priorities, goals, structure and optimization of validation approaches
Qualification
Required
Bachelors of science degree in Pharmacy, Engineering or Science is required
3+ years of experience in validation and life sciences engineering is required
Expertise with the following equipment; bottle fillers, blister fillers, cappers, case packers, labelers, bar coding, and Uhlmann thermoforms
Knowledge of cGMP Cleaning Validation and Process Validation requirements
Experience working in FDA/cGMP compliant environment required
Strong collaboration, communication, and presentation skills required
Expert-level proficiency with Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required
Company
Automated Systems, Inc. (ASI)
Founded in 1989 by Laszlo Kulcsar as a premiere systems integrator specializing in the most demanding pharmaceutical applications.
51-200 employees
H1B Sponsorship
Automated Systems, Inc. (ASI) 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
2024 (1)
Funding
Current Stage
Growth StageLeadership Team
Ray Rugebregt
CEO
John Tetrault
Chief Technology Officer
Company data provided by crunchbase