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Production/Validation Engineer – Orthobiologic – 2972136

We are seeking a Production/Validation Engineer to play a key role in manufacturing validation, process improvement, and supplier coordination within a fast-paced environment. This position involves executing and developing IQ/OQ/PQ protocols, managing testing processes with subcontractors, and ensuring seamless design transfer for new products. The ideal candidate will have a strong background in production validation, risk management, and continuous improvement while supporting quality management system (QMS) audits, non-conformances (NC), and CAPA investigations.

Responsibilities:

• Execute IQ/OQ/PQ protocols and contribute to protocol development.
• Oversee production validation processes and maintain comprehensive documentation.
• Manage testing activities with subcontractors, including report preparation.
• Perform incoming goods inspections and logistics coordination.
• Contribute to risk management through identification and mitigation strategies.
• Handle supplier coordination, including:
• Manufacturing order preparation.
• Supplier reviews and audits.
• SCAR (Supplier Corrective Action Request) support.
• Drive continuous improvement efforts by:
• Collecting and analyzing production data.
• Developing and implementing process improvements.
• Troubleshooting and optimizing production challenges.
• Support QMS audits led by QA.
• Collaborate with Product Development Teams on:
• Design transfer planning and execution.
• Manufacturing planning for new product introductions.
• Supplier identification and qualification.
• Preparation and execution of Validation Master Plans.
• Assist in NC and CAPA investigations.

Requirements:

• 5+ years of experience in manufacturing, validation, or production engineering.
• Strong expertise in IQ/OQ/PQ protocol execution and validation processes.
• Experience with supplier management, logistics coordination, and risk mitigation.
• Ability to analyze production data and implement continuous improvement initiatives.
• Hands-on experience in manufacturing planning, design transfer, and process troubleshooting.
• Familiarity with QMS audits, CAPA investigations, and compliance requirements.
• Ability to work cross-functionally with QA, supply chain, and product development teams.

Compensation: Competitive based on experience.

Years of Experience: 5+

Degree: BA/BS

Location: Maryland

This job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs.

Legacy MedSearch has been consecutively featured on Forbes’ list of Best Recruiting Firms in America for 5 years running (2019–2024).