Validation Engineer

Job Title: Validation EngineerLocation: Boston, MA (Onsite)Employment Type: ContractOverview:Validation Engineer responsible for supporting validation activities for manufacturing equipment, processes, and systems within a medical device manufacturing environment while ensuring compliance with regulatory and quality standards.Required Qualifications:Bachelor’s degree in Engineering or related field3+ years of Validation Engineering experience in the medical device or healthcare industryExperience with equipment validation, process validation, and IQ/OQ/PQ protocolsKnowledge of GMP, FDA, and ISO 13485 regulationsExperience with CAPA, deviation investigations, and root cause analysisStrong documentation and technical writing skillsKey Responsibilities:Execute validation activities for manufacturing equipment, processes, and systemsDevelop and review IQ/OQ/PQ protocols and validation reportsSupport deviation investigations and implement corrective actionsEnsure validation activities comply with regulatory and quality standardsCollaborate with Manufacturing, Quality, and Engineering teams on validation projectsMaintain validation documentation and support continuous improvement initiativesPreferred Qualifications:Experience in cleanroom or regulated manufacturing environmentsFamiliarity with risk assessments and statistical analysis tools