Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a 2D Barcode Labeling Software Validation Engineer 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 high-caliber Validation Engineer to play a key role in the strategic implementation of 2D barcode labeling requirements related to EU MDR compliance. This role will focus on designing and executing the overall validation strategy for equipment and software supporting barcode labeling systems.

This position is not limited to tactical validation execution. The selected candidate will help define and implement the overall validation framework, including Equipment Qualification (IQ/OQ/PQ) and Software Validation associated with labeling systems, barcode technology, and regulatory compliance initiatives.

The ideal candidate will have experience working within regulated manufacturing environments, particularly in medical device or life sciences industries, and possess strong expertise in validation planning, labeling standards (UDI/GTIN), and regulatory requirements such as EU MDR.

Key Responsibilities:

• Lead the validation strategy and execution for implementation of 2D barcode systems supporting EU MDR compliance.
• Design and implement equipment qualification and software validation protocols including IQ, OQ, and PQ.
• Develop validation documentation including validation plans, risk assessments, protocols, and reports.
• Support the implementation and validation of labeling systems compliant with UDI, GTIN, EU MDR, GS1, and HIBC standards.
• Collaborate with engineering, quality, IT, regulatory, and manufacturing teams to ensure validation requirements are met.
• Work with equipment and software suppliers to support validation activities and system implementation.
• Participate in change control processes, ensuring all system modifications meet validation and regulatory requirements.
• Support process validation and production readiness activities, including PPAP documentation where applicable.
• Ensure all validation activities comply with regulatory standards and internal quality systems.
• Identify risks and develop mitigation strategies for validation and compliance activities.

Qualifications:

• Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline
• 5–10+ years of validation experience in regulated manufacturing environments
• Experience designing and executing equipment qualification and validation strategies
• Experience with UDI, GTIN, EU MDR, GS1, or HIBC labeling standards
• Experience with change control processes
• Experience working with external suppliers and system integrators
• Familiarity with PPAP and product/process validation requirements
• Experience with ValGenesis validation management systems - PREFERRED
• Background in medical device, pharmaceutical, or highly regulated manufacturing environments - PREFERRED
• Experience implementing barcode labeling systems and serialization initiatives - PREFERRED
• Strong understanding of quality systems and regulatory compliance - PREFERRED