Job DescriptionWe are looking for a Manufacturing Process Engineer to join our Engineering Team in Abbvie, Westport.
This is a fixed term contract for 12 months.
This position reports to the Associate Director of Pharma Maintenance.
The successful candidate provides technical assistance for equipment/machinery and all aspects of performance around the manufacturing and aseptic filling of AbbVie products to customer requirements, FDA, HPRA, EPA and safety standards within budget parameters.
You need to have active communication and engagement with many stakeholders within the business (i.e.
E&T, Validations, QA, Vendors, Contractors, etc.)
to achieve the Site goals.Roles and ResponsibilitiesAssist with management, engineering, process improvement, equipment reliability, and control system activities.Identify, plan, schedule, manage and communicate on production related projects to all affected stakeholders.Implement lean technologies such as standard work, visualisation boards.Support the business by developing robust process & systems to ensure delivery of effective quality.Ensure that line processes, equipment and materials are maintained to deliver consistent, reliable and predictable process performance and product quality.Develop & implement systems & structure to minimise technical downtime on the line.Resolve and lead technical issues in an effective & timely manner with the technical team to support operations.Drive continuous improvement and process efficiency programs, i.e., MEP, OEE, OPEX, RCA, RCM and productivity output for the business.Manage external vendors and services for equipment and technologyManage the technical documentation, reports, files, logs and records for the department.Assist with the trending, monitoring, performance of equipment and the reduction of unplanned downtime.Help manage, track and monitor the relevant KPIs for the Technical Team.Assist with the trending, monitoring and reduction of repeat deviations associated with the equipment and technology.
Generate and approve associated change controls and relevant protocols.Help support the BU during regulatory and compliance audits.Become an SME for the Aseptic Fill and Packaging operations equipmentQualificationsDegree in Mechanical, Electrical or Process Engineering4+ years experience working in a regulated environment (Pharmaceutical/Medical Device).Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.Computer literate with experience of: Maximo, SAP, Trackwise and working with Microsoft Office (Word, Excel, PowerPoint etc.
).Strong ability to evaluate, diagnose and troubleshoot problems.Flexibility to respond to issues outside normal business hours.Ability to learn new and different technologies.Experience in high volume automation Pharmaceutical manufacturing environment.Ability to organize workload and work on own initiative.Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:>