Manufacturing Business System Analyst
Overall Purpose: Aerie pharmaceutical, a clinical stage Pharmaceutical start up in athlone are looking for aManufacturing Business Systems Analyst to join their team.The Manufacturing Business Systems Analyst will lead site and global focus on buildout of ERP (Enterprise Resource Planning) and MES (Manufacturing Execution System) applications to support manufacturing, quality and supply chain processes. It is a key role that acts to translate Manufacturing and Supply Chain requirements and best practice into simple and effective IT business solutions that meets the needs of the Athlone site and the wider business. The ERP/MES Business Systems Analyst will work very closely with Athlone Manufacturing and Supply Chain colleagues and with global IT and Supply Chain functions to ensure new and existing systems are focused on business need. The successful candidate will be responsible for ensuring that all new ERP and MES solutions are fully compliant with GMP and regulatory expectations. This position will also lead the site deployment program for ERP and MES applications. This role reports to the Global IT Director. Essential Duties, Functions and Responsibilities: Works with manufacturing, supply chain and quality colleagues as part of a site team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site. Prioritises safety and plays their role in ensuring a site culture that has safety as its first focus and ensures that site systems, tools and procedures reflect this safety culture. Translates business process requirements into ERP and MES solutions that are simple, scalable and focused on the business users in Manufacturing, Quality and Supply Chain. This includes developing user requirements, system configuration and integrations that meet the needs of the site and based on structed analysis of the relevant business processes. Ensures IT colleagues understand the business users requirements in new ERP and MES deployment programs. Works with project teams and business process owners in Manufacturing, Quality and Supply Chain to ensure tasks are accomplished within defined timeframes at the highest quality with attention given to detail and scalability. Leads site support for deployed ERP and MES systems to support site goals and objectives. The role will initially include the development of business requirements and supporting the work required for delivery of defined analysis and design concept activities by eliciting, documenting and managing business requirements using interviews, analysis of documents, requirements workshops, surveys, site visits, business process descriptions, use cases, scenarios, workflow analysis and other relevant techniques (e.g. Process Mapping, Value Stream Mapping. Identify areas of continuous improvement in business processes and system interfaces pertaining to Manufacturing and related processes, with a focus on process reengineering and systems solutions. Lead ERP and MES project management tasks including SDLC documents and validation activities while tracking project activity using structure project management tools. Use excellent collaboration skills to work with cross-functional groups and contractors (locally and remotely located) to ensure successful and timely deliverables. Communicate and work collaboratively with global Aerie colleagues who are supporting site ERP and/or MES functionality and/or leading deployment of other back office ERP systems. Ensure site ERP and MES GMP functionality is validated according to GAMP expectations and that the integrity of system data is built into system design and deployment. Skills/Knowledge Required: In-depth knowledge of manufacturing, supply chain and quality business process in a pharmaceutical context. Strong interpersonal and communication skills and ability to interact positively with all levels of the organization and must be able to work as part of a team as well as individually. Independent and demonstrable business analysis skills coupled with structure and disciplined problem solving skills. Education Required : Requires a Bachelors Degree in a IT/business or engineering/science discipline and has ideally worked in a professional role within pharmaceutical manufacturing or supply chain management. Experience Required: At least 10 years’ relevant experience in a pharmaceutical manufacturing environment, with at least 5 years’ experience supporting Enterprise Applications such as ERP and MES. Experience (ideally leading) business systems implementation, including knowledge of GAMP (Good Automation Manufacturing Practice) and SDLC (Software Development Life Cycle) management. Working knowledge of system integrations requirements, technology and design. Strong exposure to MES and ERP technologies, including automated data collection, visualization, quality and efficiency in manufacturing, automation, workflow, database application, scheduling, and interface between MES and ERP and other enterprise systems. Has worked with manufacturing and supply chain colleagues to build business case justification for investment in MES and ERP applications that meet business needs. Experience in the application of Manufacturing systems, including information exchange, integration requirements and master data. Experience in one or more of the following systems a plus: CMMS, LIMS, QMS, Content Mgmt. Has experience in front of regulatory inspectors (FDA, HPRA, etc.) to explain ERP and MES validation approaches and data integrity procedures. For more infomration send your cv in confidence to firstname.lastname@example.org or call me on 01 947 6227. This job originally appeared on RecruitIreland.com.
112 days ago