IT Analyst Manufacturing System MES

Overview

This position reports to the IT Manager Manufacturing Systems. The MES Analyst will serve as a key liaison between the MES IT group and various business functions (Supply Chain Manufacturing Quality MSAT) ensuring business requirements and requests are gathered documented implemented and validated. This position will provideoperational support perform and document configuration updates and maintain the Syncade Manufacturing System (MES). This role will focus on ensuring business needs are met as we progress with digitalization of the Iovance manufacturing site.

Essential Functions and Responsibilities

• Key liaison between IT and business groups gathering business requirements and defining functional specifications for enhancements/recipes authoring/reviewing procedures and work instructions
• Partner with business teams learn business processes and drive continuous improvement initiatives to provide operational efficiencies and cost reductions.
• Author and execute MES validation/SDLC documentation in collaboration with CSV team URS FS CS IOQ etc.
• Perform general engineering tasks related to MES as delegated by the system owner (IT Manager) such as Recipe Authoring Equipment Tracking configuration administrationlevel configuration updates report configuration (Crystal Reports) datamining (SQL query authoring) etc.
• Perform operational activities (e.g. enduser support breakfix) for many aspects of the MES system (Equipment Tracking/Workflows Order/Inventory Management interface to ERP etc. oncall support required.
• Create and maintain environment architecture diagrams system admin proceduresuser procedures and work instructions.
• Assist QA and Supply Chain with investigations data reporting from MES
• Act as a system analyst and technical resource for major MES projects (electronic equipment logbooks deployment Electronic Batch Records)
• Adhere to Iovance Biotherapeutics core values policies procedures and business ethics.

Travel

• Minimal travel requirements (less than 5
• If remote on average > 3 days/week at the Philadelphia manufacturing site

Required Education Skills and Knowledge

• Bachelors degree (preferably Computer Science/Engineering or Chemical/Biomedical Engineering)
• Experience in cell therapy/biopharmaceutical IT and/or manufacturing operations 1 3 years)
• Experience serving as a System Analyst in a regulated GMP environment
• Experience validating implementing supporting and/or as an end user utilizing Syncade MES or related MES (PASX Tulip etc).
• Experience with project management (e.g. SDLC waterfall) a plus.

Preferred Education Skills and Knowledge

• At least 2 years of handson experience and exposure working in biotech/pharma information technology.
• Experience with Computer System Validation (CSV) preferably in a paperless environment (KNEAT).
• Experience implementing and administering Emerson Syncade
• Experience supporting a site utilizing electronic batch records
• Experience providing enduser IT support in a regulated environment
• Familiarity with CFR 21 Part 11 cGMP Annex 11 SOX compliance etc
• Strong interpersonal presentation and communication skills.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
• Can work as an effective team resource as well as independently.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office andexert 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.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures viewing a computer screen and extensive reading.
• This position requires repetitive motion substantial movements (motions) of the wrist hands and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment troubleshooting problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 .

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