Validation Engineer – Equipment (IQ/OQ)
Title: Validation Engineer – Equipment (IQ/OQ)Location: Bethel, CT (Onsite)Employment Type: Contract (12 Months)Status: Accepting CandidatesAbout the roleJoin an engineering team supporting equipment validation activities within a regulated manufacturing environment. This role focuses on performing installation qualification (IQ) and operational qualification (OQ) activities to support new equipment integration and production readiness.The ideal candidate will have strong experience supporting equipment validation activities in medical device or regulated manufacturing environments.Key ResponsibilitiesPerform Installation Qualification (IQ) and Operational Qualification (OQ) activities for manufacturing equipmentSupport validation of approximately 100 pieces of equipment during facility expansion activitiesDevelop and execute validation protocols and reportsEnsure equipment meets regulatory and operational requirementsCollaborate with engineering and manufacturing teams to support equipment startupReview equipment documentation and support validation readinessSupport troubleshooting during validation activitiesMaintain compliance with ISO 9001 and ISO 13485 quality standardsDocument validation results and maintain validation recordsSupport risk-based validation activities and continuous improvement effortsCoordinate with cross-functional teams to ensure timely completion of validation milestonesQualificationsBachelor’s degree in Engineering or related field (Preferred)Experience performing IQ and OQ validation activitiesExperience working in medical device or regulated manufacturing environmentsExperience working under ISO 9001 and ISO 13485 standardsExperience supporting equipment validation activitiesExperience reviewing technical documentation and validation protocolsStrong documentation and technical writing skillsStrong troubleshooting and problem-solving skillsAbility to manage multiple validation activities simultaneouslyAbility to work onsite in a manufacturing environmentPreferred QualificationsExperience supporting tube drawing or metal drawing processesExperience supporting equipment transfer or installation projectsExperience supporting TMV (Test Method Validation) activitiesExperience supporting large-scale equipment validation programsExperience supporting manufacturing facility expansionsCompensationEstimated hourly range: $65/hr (W-2)Final rate within this range will be based on skills, experience, and interview results.Work Schedule: 100% OnsiteContract Duration: 12 Months