Validation Engineer
Raritan, NJ (Hybrid 4-days a week)
12 Month Contract
(Potential for Extension/Conversion)
We are seeking a Validation Engineer to join one of our Fortune 500 partners within the
Healthcare, Life Science, and Medical Device space in Raritan, NJ working on a hybrid
schedule. The Validation Engineer will be responsible for ensuring that our medical devices meet
all regulatory and quality standards through rigorous validation and testing processes.
Key Responsibilities:
• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and
software.
• Conduct risk assessments and create validation plans in compliance with FDA, ISO, and
other regulatory requirements.
• Perform data analysis and generate validation reports to document findings and ensure
compliance.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and
Manufacturing, to support validation activities.
• Investigate and resolve validation-related issues and non-conformances.
• Maintain validation documentation and ensure it is up-to-date and audit ready.
• Participate in internal and external audits as a subject matter expert on validation
processes.
• Stay current with industry trends and advancements in validation methodologies and
regulatory requirements.
Qualifications:
• Bachelor’s degree in engineering, Life Sciences, or a related field.
• Minimum of 1-3 years of experience in validation engineering, preferably in the medical
device industry.
• Strong knowledge of FDA regulations, ISO standards, and GMP requirements.
• Proficiency in validation software and tools.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.
• Attention to detail and a commitment to quality.
