Validation Engineer

Legacy MEDSearch; Maryland; On-site; USD 50,000 - 240,000; Full time

Job summary

A leading recruitment firm in the medical devices sector is seeking a Production/Validation Engineer in Maryland. This role is pivotal in executing validation protocols and enhancing manufacturing processes. Candidates should possess a robust background in production validation and risk management, along with experience in quality management audits.

Qualifications

• 5+ years of experience in manufacturing, validation, or production engineering.
• Strong expertise in IQ/OQ/PQ protocols and validation processes.
• Familiarity with QMS audits, CAPA investigations, and compliance.

Responsibilities

• Execute IQ/OQ/PQ protocols and maintain comprehensive documentation.
• Oversee production validation processes and manage testing activities with subcontractors.
• Contribute to risk management and support QMS audits.

Skills

Manufacturing

Validation

Risk Management

Continuous Improvement

Education

BA/BS

Job description

1 day ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Legacy MEDSearch

Practice Leader at Legacy MedSearch - Medical Device Recruiters | 2019, 2020, 2021, 2022, 2023 Forbes Americas Best Executive Recruiting Firms

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.
• Manufacturing order preparation.
• Supplier reviews and audits.
• 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.
• 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).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Production

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Legacy MEDSearch by 2x

Sign in to set job alerts for “Validation Engineer” roles.

Frederick County, MD $50,000.00-$240,000.00 1 day ago

Frederick County, MD $50,000.00-$240,000.00 1 day ago

Annapolis, MD $85,000.00-$160,000.00 1 week ago

Lead Validation Engineer or Specialist, Equipment

Silver Spring, MD $122,000.00-$150,000.00 1 week ago

Clarksburg, MD $99,995.00-$127,771.00 1 week ago

Annapolis Junction, MD $12,000.00-$180,000.00 1 month ago

Quality Engineer (Must Have Complaint Investigation)

Quality Engineer [Must have Complaint Handling exp]

Fort Meade, MD $95,000.00-$200,000.00 5 months ago

Quality Control Area Engineer - Track and Systems

North East, MD $115,000.00-$165,000.00 1 day ago

North East, MD $120,000.00-$175,000.00 1 day ago

Walkersville, MD $100,000.00-$170,000.00 3 days ago

Columbia, MD $130,000.00-$180,000.00 1 month ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.