Automated Technology (Phil.) Inc. - ATEC ยท 1 month ago
Equipment Validation Engineer
Chicago, IL
Full-time
Onsite
Mid Level
$42.50/hr - $53.50/hr
3+ years expAutomated Systems, Inc. is seeking a highly skilled Equipment Validation Engineer to support one of their leading pharmaceutical manufacturing clients. The role involves project planning, coordination, and execution in equipment validation and quality assurance, ensuring compliance with safety and regulatory standards.
IndustrialIndustrial DesignManufacturingSemiconductor
Responsibilities
Partner with the Quality Manager and cross-functional teams to drive company-wide quality objectives, enhancing product quality and operational efficiency
Identify and resolve system inefficiencies that contribute to quality-related costs
Lead and manage equipment validation activities, including protocol creation and execution (IQ/OQ/PQ)
Coordinate and oversee change control processes across assigned projects
Conduct and review customer complaint investigations and related corrective actions to ensure compliance with FDA, QSR, ISO, and customer requirements
Apply CAPA methodologies and problem-solving tools including FMEA, DOE, SPC,Cause & Effect analysis, and Flow Charts
Analyze statistical data to evaluate current standards and support quality improvement initiatives
Assess compliance of processes and outcomes against specifications, SOPs, and regulatory standards
Develop and review product specifications, ensuring accuracy and alignment with quality expectations
Plan and execute Supplier Quality evaluations, including supplier audits and performance assessments
Support and maintain quality agreements with assigned suppliers
Deliver training across internal departments on topics such as DOE, GR&R, statistics, sampling plans, and key quality principles
Act as a liaison with customers to clarify requirements, support audits, and ensure alignment with quality objectives
Assist in sustaining compliance with ISO standards and FDA QSR requirements
Contribute to Continuous Improvement initiatives using Six Sigma tools and methodologies
Perform additional duties as needed to support the Quality organization
Qualification
Required
Bachelor's degree in Engineering, Science, or a related field
Strong verbal and written communication skills, with the ability to clearly articulate technical information
Proficiency with advanced mathematical concepts and intermediate statistical analysis (SPC)
Intermediate proficiency in Microsoft Office
Ability to work independently using verbal and written instructions
Strong understanding of how individual responsibilities align with broader Quality objectives
Preferred
3+ years of experience in a Quality or Validation role strongly preferred
Experience in the Medical Device industry (ISO 13485) strongly preferred
Hands-on experience with equipment validation and IQ/OQ/PQ protocols is preferred
Prior experience in an onsite manufacturing environment is highly advantageous
Six Sigma training or certification preferred
SAP experience preferred
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