<p>Overview</p> <p>This position reports to the Manager, IT Manufacturing Systems. The MES (Manufacturing Execution System) Engineer will utilize their expertise in Syncade MES Recipe Authoring to develop and maintain a robust, lean, and reliable Electronic Batch Record (EBR) to support Iovance's cell therapy manufacturing process.</p> <p>The MES (manufacturing execution system) Engineer will serve as a technical resource, providing operational support, performing configuration/documentation updates, and maintaining the Syncade Manufacturing Execution System (MES).</p> <p>As well as being an operational and application support resource, the role will partner with the functions (Manufacturing, Quality, MSAT, R&D) to ensure IT at Iovance is maintaining and delivering systems to meet the business requirements.</p> <p>Essential Functions and Responsibilities</p> <ul> <li> <p>Perform general engineering tasks related to MES, as delegated by the system owner (IT Manager), such as Recipe Authoring, Equipment Tracking configuration, administration-level configuration updates, report configuration (Crystal Reports), data mining (SQL query authoring), etc.</p> </li><li> <p>Assist team with operational activities (e.g. end-user support, break-fix) for all aspects of MES system (Electronic Batch Record/Recipe Authoring, Equipment Tracking/Workflows, Order/Inventory Management, interface to external systems/instruments, etc.) - on-call support required.</p> </li><li> <p>Act as technical resource for major MES projects (EBR authoring and deployment)</p> </li><li> <p>Knowledge of pharmaceutical business processes, Part 11 data integrity, infrastructure, architecture, and technology to support business supporting manufacturing.</p> </li><li> <p>Partner with business teams, learn business processes and drive continuous improvement initiatives to provide operational efficiencies and cost reductions.</p> </li><li> <p>Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.</p> </li><li> <p>Perform miscellaneous duties as assigned.</p> </li></ul> <p>Travel</p> <ul> <li>Travel requirements less than 10% </li><li>On-site at Philadelphia manufacturing facility > 80% </li></ul> <p>Required Education, Skills, and Knowledge</p> <ul> <li>2-4 years of hands-on experience and exposure working in biotech/pharma information technology and/or consulting for the pharmaceutical industry. </li><li>A minimum of 1 year of experience performing Recipe Authoring within Emerson Syncade MES. </li><li>Bachelor's degree required, preferably in Computer Science, Engineering, Chemical/Biomedical Engineering, or similar field of study </li><li>Experience in pharmaceutical and/or medical device industries. </li><li>Strong understanding of CRF 21 Part 11, Annex 11, cGMP, GAMP5 </li></ul> <p>Preferred Education, Skills, and Knowledge</p> <ul> <li>Experience implementing and administering MES (Emerson Syncade) </li><li>Familiarity with the back-end design, operation and the supporting database structure of Syncade MES is a plus. </li><li>Experience configuring interfaces between MES and external systems (ERP, LIMS, BMRAM, etc) and instruments (cell counters, scales, etc) is a plus </li><li>Experience with Iovance's additional systems including ERP (NetSuite), Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain) is a plus. </li><li>Experience with Computer System Validation (CSV) is highly preferred. </li><li>Experience with cell and gene therapy/biologics manufacturing preferred. </li><li>Strong interpersonal, presentation and communication skills. </li><li>Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions. </li><li>Can work as an effective team resource as well as independently. </li></ul> <p>The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.</p> <p>Physical Demands and Activities Required</p> <ul> <li>Must be able to remain in a stationary position standing or sitting for prolonged periods of time. </li><li>Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. </li><li>Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. </li><li>This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. </li><li>Must be able to communicate with others to exchange information. </li></ul> <p>Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines</p> <p>Work Environment</p> <p>This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.</p> <p>The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.</p> <p>Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.</p> <p>By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.</p> <p>#LI-onsite</p>