Validation Engineer - Equipment & Automation (Medical Device)

Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Validation Engineer - Equipment & Automation for a 12-month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.

We are seeking a Validation Engineer to lead and support validation activities for manufacturing equipment and automation systems in a regulated medical device environment. This role is responsible for ensuring equipment and automated systems are installed, qualified, and maintained in compliance with FDA, ISO 13485, and other applicable regulations.

Responsibilities

Develop and execute validation protocols (IQ/OQ/PQ) for new and modified equipment and automation systems.

Author and review validation plans, summary reports, and risk assessments.

Collaborate with engineering, quality, and manufacturing teams to define validation requirements and acceptance criteria.

Ensure equipment meets URS (User Requirement Specifications) and is validated in accordance with cGMP and 21 CFR Part 11.

Perform data analysis and troubleshooting during validation activities to ensure performance and reliability.

Maintain validation documentation and ensure audit readiness.

Support equipment lifecycle activities including change control, re-validation, and periodic reviews.

Contribute to continuous improvement initiatives involving equipment performance, process optimization, and compliance.

Requirements

Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline).

3+ years of validation experience in a medical device or pharmaceutical manufacturing environment.

Strong knowledge of FDA QSR, ISO 13485, GAMP 5, and 21 CFR Part 11.

Experience validating automated equipment, robotics, or vision inspection systems preferred.

Excellent documentation and communication skills.

Proficiency with Microsoft Office and validation management systems

Preferred Skills:

Six Sigma or Lean Manufacturing certification.

Familiarity with PLCs, SCADA systems, and cleanroom/GMP environments.

Experience supporting FDA inspections or third-party audits.Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.

Benefits:

401(k) matching

Comprehensive dental, vision, and health insurance

Flexible schedule options

Health savings account

Life insurance

Paid time off

Professional development assistance

Employee assistance and discount programs

Referral program

Retirement plan

Tuition reimbursement

iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential.

Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!

Contact us today to learn more:

*** Grand Rapids, Michigan:

*** Tampa, Florida:

***

*** Chat with us live: