Validation Engineer

Become a part of our industry-leading and engineering-driven precision injection molding  business for over four decades, our expansive facilities, specialized machinery, and expert team members
are representative of the top-notch work environment you’ll find at Chemtech Plastics.

Employee benefits are a top priority at Chemtech Plastics, which is why we've c reated a comprehensive benefits package to support you in your personal life and future planning. T his includes competitive pay, life insurance, continuing education assistance, 401K, and more.

Employer matching

Health

Vision

Paid Vacation

Disability (Short- and Long-Term)

Position:Validation Engineer

Location: Elgin, IL

Job :183

# of Openings:1

Validation Engineer

1st shift

E-Verify

• Participate in projects/program management, review new and existing drawings as received from customers and evaluate potential quality issues.
• Develop and execute IQ, OQ, and PQ validation protocols for production processes, equipment and software in a timely and cost-effective manner.
• Write reports summarizing results for equipment, process or software validation projects.
• Determine deliverables with the customer and cost estimate the sampling requirements and inspection activity.
• Review existing validation reports and identify/mitigate gaps for compliance to requirements
• Work with Q.A. Dept. on piece part inspections and capability studies of new mold and engineering changes to ensure all requirements are completed and approved.
• Conduct or lead corrective and preventive actions in quality systems or validations using problem solving techniques.
• Participate as an active new product development core team member.
• Process all stages of validation documents and oversee the completion and signatures.
• Support quality system projects and activities such as engineering change order support and complaint investigation support.
• Support FDA inspection readiness activities.
• Interfacing customers, staff and fellow managers to establish and maintain validation schedules throughout the company.
• Ability to interact with customers in all necessary situations to keep them informed of progress and documentation status.
• Consults with customers on quality and inspection-related issues.
• Manages and holds project meetings with customers.
• Other duties as assigned by the Director of Engineering.

• Excellent written and verbal communication skills and highly effective time management skills.
• Ability to operate independently and as part of a team
• Independent problem-solving skills
• Proficient in root cause analysis, verification & validation, process flow mapping
• Technical and procedural understanding of customer requirements for part validation.
• Project management skills include planning, processing, organizing and tracking of all part validation activities.
• Experience processing data in Mini Tab software and correlate P values.
• Knowledge of processes and procedures for cost estimating of validation work.

• Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 3-5 years of process/software validation experience in a regulated industry
• Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift 15 lbs.
• Must be able to access and navigate each department at the organization’s facilities.

• Full benefit offerings including medical, dental, vision, and voluntary plans
• DQS-Certified for IATF 16949 : 2016 and ISO 9001 : 2015