Maintenance Engineer
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Maintenance EngineerChantilly, VirginiaFull TimeThe Maintenance Engineer will be responsible for ensuring the reliability, performance, and compliance of pharmaceutical manufacturing equipment within an Oral Solid Dosage (OSD) environment. This role involves hands-on maintenance, troubleshooting, validation support, and continuous improvement of production equipment to ensure safe and efficient operations.Key ResponsibilitiesPerform preventive, predictive, and corrective maintenance on OSD manufacturing equipmentMaintain and troubleshoot equipment including:Blenders, granulators, millsFluid bed coatersTablet presses and capsule fillersCoating machinesPackaging lines (bottle, blister, cartoners)Troubleshoot mechanical, electrical, pneumatic, and automation systemsSupport installation, commissioning, IQ/OQ/PQ qualification, and validation activitiesMaintain accurate records in CMMS systems (work orders, logs, maintenance history)Ensure compliance with cGMP, FDA, and safety regulationsCollaborate with Production, Quality, and Engineering teamsConduct Root Cause Analysis (RCA) and implement CAPASupport audits, inspections, and regulatory documentationManage spare parts inventory and equipment reliability initiativesIdentify opportunities for process improvement and equipment upgradesMust-Have RequirementsBachelor's degree in Mechanical, Electrical, Industrial Engineering or related field (or equivalent experience)4+ years of maintenance experience in pharmaceutical OSD manufacturing (mandatory)Strong hands-on experience with OSD equipment (blenders, granulators, tablet presses, coating, packaging lines)Experience supporting IQ/OQ/PQ validation activitiesAbility to troubleshoot across mechanical, electrical, pneumatic, and automation systemsAbility to read mechanical drawings, electrical schematics, and manualsRequired SkillsStrong knowledge of cGMP and FDA regulationsHands-on troubleshooting and maintenance expertiseExperience with CMMS systems and documentationStrong analytical and problem-solving skillsAbility to work independently and in cross-functional teamsStrong communication and documentation skillsPreferred / Nice-to-Have SkillsExperience with PLC, HMI, SCADA (automation systems)Knowledge of HVAC, compressed air, and utility systemsFamiliarity with lean manufacturing and reliability engineeringCore CompetenciesTroubleshooting and technical expertiseAttention to detail and compliance focusTeam collaboration and communicationContinuous improvement mindsetTime management and reliabilityEducationBachelor's Degree in Engineering or related field (Required)Recruiter Submission Template:Full Name:Degree Major with University and Completion Year:Years of Pharmaceutical OSD Maintenance Experience:Experience with OSD Equipment (Blenders, Granulators, Tablet Press, Coating, Packaging – Details):Experience with IQ/OQ/PQ Validation (Details):Troubleshooting Experience (Mechanical/Electrical/Pneumatic/Automation – Details):Experience with CMMS Systems (Details):Experience with cGMP / FDA Compliance (Details):Automation Experience (PLC/HMI/SCADA – Y/N & Details):Utility Systems Experience (HVAC / Compressed Air – Details):Motivation / Reason for Relocation (if not local):Motivation / Reason for interest in this position:Contact Number:Email ID:LinkedIn Profile URL:Full Address (Street, City, State, Zip Code):Notice Period (in weeks):Current Work Authorization Status:Expected Salary:Are you able to relocate on your own expenses and work in Chantilly, Virginia?