Senior Manufacturing Engineer

Professional ExperienceSenior Manufacturing Support EngineerPharmaceutical Manufacturing Operations Billerica, MAManufacturing Equipment SupportProvide advanced troubleshooting and rapid recovery support for pharmaceutical manufacturing equipment to minimize downtime and maintain production schedules.Serve as Subject Matter Expert (SME) for critical equipment including isolators, vial filling lines, lyophilizers, sterilizers, washers, and packaging systems.Monitor process operations to ensure compliance with manufacturing specifications and cGMP regulations.Process Equipment ReliabilityMaintain operational readiness of sterile filling and process equipment supporting continuous manufacturing operations.Troubleshoot complex issues involving mechanical, electrical, automation, and process systems.Operate production equipment for setup, testing, or manufacturing support as required.Validation & Compliance SupportSupport validation maintenance programs and equipment re-qualification activities.Assist Validation Engineers during FAT, SAT, IQ, OQ, and PQ activities for new or modified equipment.Maintain equipment documentation and records to support validated manufacturing operations.Quality & Regulatory SupportSupport change control, deviations, and CAPA investigations within TrackWise or similar systems.Ensure compliance with FDA regulations and current Good Manufacturing Practices (cGMP).Assist with maintenance SOP improvements and documentation updates.Engineering & Process SupportSupport Manufacturing Engineers with retrofit, improvement, and upgrade projects for manufacturing and critical systems.Provide mentorship and technical support to peers within engineering and maintenance teams.Operational SupportParticipate in 24/7 on-call support for critical manufacturing equipment.Perform non-routine and off-hours troubleshooting activities when required.Ensure safe work practices and adherence to company safety policies.Technical SkillsSystems & SoftwareCMMS SystemsTrackWiseMasterControlLMSBuilding Automation SystemsMicrosoft Office SuiteTechnical SkillsMechanical SystemsElectrical SystemsAutomation SystemsEquipment MaintenanceProcess Equipment TroubleshootingEngineering Drawings & SchematicsEducationBachelor of Science – Mechanical Engineering (Preferred) or equivalent engineering experienceAssociate Degree – STEM Field (Optional)High School Diploma or EquivalentCertifications & TrainingcGMP TrainingHAZMAT TrainingState Boiler License (Preferred / Obtain within 6 months)Electrician License (Preferred)Technical Certifications (Preferred)Additional QualificationsKnowledge of aseptic manufacturing techniquesExperience in pharmaceutical plant operations and maintenance environmentsAbility to read and create engineering drawings and schematicsProficient in hand tools, power equipment, and production machineryValid Driver’s LicensePhysical & Work EnvironmentAbility to lift up to 70 lbsWork in manufacturing, laboratory, and warehouse environmentsExposure to noise, temperature variations, and controlled radiation levelsUse of PPE including safety shoes, glasses, and gloves