MANUFACTURING IS SYSTEMS ARCHITECT

Manufacturing IS Systems Architect
Contract, Dublin

The successful consultant will be responsible for the delivery of new and updated integration functionalities for Manufacturing Information Systems for use in production. Responsible for oversight on alignment of Manufacturing Information Systems with Global Operating Specifications. 


Responsibilities include:

Development, configuration and testing for integration components of Master Batch Records (MBRs) from initial to final design. 

Leading integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions 

Equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing 

Liaising with Plant Support, System Owner and Operations teams regarding documentation changes in an effective and timely manner 

Support and updates to Recipe Control system

MBR design oversight, support and ongoing development of the MES system 

Training of Electronic Batch Record (EBR) designers and end-users on MES integration activities and development of job aids 

Support and to assist in fast Manufacturing Execution System (MES) issue resolution where required and as directed by Operations leadership 

Development, review and update MES Standard Operating Procedures and Design Specifications 

Continuous improvement & Projects

Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities for MES integration removing paper from the execution and review process to reduce cycle times 

Support implementation of process changes 

Safety
Responsible to perform all activities in compliance with safety standards and site safety procedures.

Preferred Experience

Working knowledge of drug product manufacturing and packaging in pharmaceutical/biotech industries or aseptic processing preferred

Knowledge of regulation requirements (including cGMP, 21CFR Part11) 

Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA) 

Knowledge of validation processes and understanding of validation protocol generation requirements 

Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, SCADA, PLC, Historian) 

Practical knowledge in continuous improvement tools and methodologies 

Required Skills

MES experience with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries 

Strong capabilities in S95 level 2 and level 3 systems and their integration. 

Strong working knowledge of OLE for Process Control, 

Experience of Supervisory Control and Data Acquisition (SCADA), Process Control Systems (PCS), Recipe Managers - Siemens, Rockwell, Kepware OPC Server, OSI Pi, RT Reports, OSI PI Asset Framework, Laboratory benchtop equipment, Learning Management Systems 

Strong exposure to MES technologies, including automated data collection, historian applications (OSI PI), visualization, quality and efficiency in manufacturing 

MES experience in implementing stable and scalable solutions for 

Continuous Data Retrieval from Level 2 and Level 3 systems 

Creation / Loading of Level 2 Recipes 

Retrieval of Alarms and Events (Batch Context Information) into MES for Annotation, Review and Trending 

Strong PL/SQL programming experience in software development with Microsoft Visual Studio / Development tools; knowledge of web services, ASP and .net technologies. 

Strong SQL experience with exposure to both Oracle & SQL Server databases along with Crystal Reports 

Strong attention to details, including the ability to proof read documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently 

Excellent organisational and communication (verbal and written) skills at all levels of the organisation