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Equipment, Controls Engineer I

4 months ago

Raleigh, United States Cellectis Full time

Job DescriptionYour position and key responsibilitiesAs the Equipment/Controls Engineer you will be our SME for Cellectis Biologic's major/critical GMP manufacturing and facilities equipment and control systems. This includes, but is not limited to, the Grade A Production Isolators and Filling Isolator; HVAC and BMS control system; and EMS.You will be accountable for routine in-house maintenance of these systems; partnering with vendors during scheduled Plant Maintenance period for PM, calibration, and equipment/system upgrades; and rapid troubleshooting and remediation when unexpected equipment/system issues arise before or during GMP production batches. In this role you will partner closely with Manufacturing, Metrology/Maintenance, and IT to keep equipment/systems in good working order and respond rapidly to operational issues.Your main activities as Equipment/Controls Engineer will includePrimary SME on Grade A Production Isolators, Filling Isolator, and vial Filling Robot - both hardware and control systems. Resolve issues to support and reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Monitor systems to identify performance risks and implement risk reduction strategies. On-site or on-call any time a GMP production batch is actively in progress in the Production or Filling Isolators. Partner with Metrology/Facilities Mechanics and Site Coordinator to maintain active inventory of spare parts. Partner with OEM for both planned Plant Maintenance Period work (PM, calibrations, upgrades) and for unplanned (emergency) work that requires immediate OEM support. Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, commissioning, startup, and validation of equipment. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering/production runs.Back-up SME for additional site sytems and infrastructure. Including HVAC, Building Monitoring System (BMS - temp/humidity control), and Environmental Monitoring System (EMS). Partner with HVAC contract service provider for both planned work (PM/replacements, calibrations, upgrades) and for unplanned (emergency) work that requires immediate support. Maintain full knowledge of the EMS for monitoring equipment and troubleshooting issues with equipment and control systems.Other responsibilities Assist other technical staff in testing, cleaning, and repairing utility systems as needed. Document all work orders and PMs in site CMMS.Your Education, Certifications, and Experience BS in Electrical/Mechanical Engineering or equivalent technical/scientific/mathematical field, preferred. 2-3 years' experience in cell and gene therapy or biologics GMP manufacturing, or build/start-up of biomanufacturing plants Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation. Solid working knowledge of PLCs, BMS, and/or EMS. Direct knowledge of design and troubleshooting with GMP production facility equipment and systems including isolator and fill equipment with VHP decontamination, filter integrity and glove integrity testers. Solid working knowledge of commercial HVAC/BMS. Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects. Preferred experience with Grade A isolators and filling equipment; willingness to attend in-house training at OEMs as needed to become expert on Cellectis Raleigh's equipment/controls Strong understanding of GMPs and good engineering practices (GEP)Your Technical Skills and Core Competencies Strong mechanical aptitude. Self-starter with a sense of urgency to analyze and solve problems. Collaborative with all stakeholders (Metrology/Maintenance, Manufacturing, Validation, QA, vendors, and service providers) and ability to communicate with various levels of site management through informed discussions and presentations. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc. Demonstrated ability to work under pressure, exercise sound judgement, and analyze/resolve problems and adapt to changing priorities as demands change. Excellent interpersonal and communication skills. Excellent verbal and written communications and presentations skills. Excellent MS Office (Word, Microsoft Excel, and PowerPoint) as well as CMMS capabilities required.