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Labeling & Equipment Qualification Engineer
Mahwah, NJ, US
Engineering
Bachelors Degree
Full Time, Temporary
$50 - $55/hr
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Mahwah, NJ, US
$50 - $55/hr
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Labeling & Equipment Qualification Engineer (EU MDR)
- Contract Duration: 12 months – Estimated to end: 3/2027 (Contract Extension Expectation)
- Location: 100% ONSITE – Mahwah, NJ (07430)
- Type: W2 contract (NO C2C OR THIRD PARTY will be considered for this role)
- Work Authorization: Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.
- Pay: Negotiable depending on direct-related experience up to $50 – $55 an hour
About the Role:
We are seeking a high-caliber engineer to lead the strategic implementation of 2D barcode solutions in support of EU MDR compliance. This role is critical for designing and shaping best practices in equipment qualification, software validation, and labeling initiatives within regulated medical device environments. You’ll collaborate cross-functionally, influence process improvements, and directly impact labeling and compliance strategies.
Note: This position does not focus on Computer System Validation (CSV). Candidates whose primary background is CSV may not be the best match for this opportunity.
What You’ll Do:
- Lead and develop validation strategy for 2D barcode projects, including GTIN, UDI, and EU MDR compliance
- Design, author, and implement validation protocols for equipment and labeling-related software systems (IQ/OQ/PQ)
- Oversee and ensure compliance with GS1 and HIBC labeling requirements
- Collaborate with suppliers to qualify both new and legacy equipment and labeling platforms
- Drive change control processes and innovate continuous quality and compliance improvements
- Support or lead PPAP (Production Part Approval Process) initiatives as needed
- Maintain impeccable validation documentation to ensure audit readiness
What We’re Looking For:
- 5–10+ years of validation experience in medical devices or regulated industries
- Strong background designing and executing validation protocols
- Proven experience with labeling systems and regulatory implementations (GTIN, UDI, EU MDR)
- Familiarity with GS1 and HIBC labeling frameworks
- Hands-on experience with change control processes
- Comfort managing supplier relationships around validation activities
- Experience with PPAP processes
- Experience using Valgenesis or similar electronic quality/validation management systems (a plus)
- Excellent analytical, documentation, and collaboration skills
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
*** (Kelly does not expense relocation/interview costs)**
10150032
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