Data Historian Senior Engineer
The successful candidate will report into the Automation IT Project Manager, specifically responsible for the PI Data Historian system and related Reporting. The Data historian Senior Engineer will be responsible for the development of key AIT quality documents, such as Quality Assurance (QAPs) and test plans, and for ensuring adherence to the QAPs. This candidate will be required to work closely with the AIT team responsible for the full Automation and IT scope and with vendors/partners with responsibility for delivery of systems.
Role Functions (Functions include, but are not limited to, the following):
- Technical design lead for the Data Historian and Reporting solution including integration to other systems such as Process Automation System and BAS.
- Actively participates in the creation of project deliverables such as design documents, configuration build, installation and validation activities as required by the Automation IT Project Manager.
- Ensure technical delivery of Data Historian and Reporting systems as endorsed by the leadership team to meet business objectives.
- Site Data Historian and Reporting platform architecture, system ownership and lifecycle management.
- Defining and maintaining the site Data Historian and Reporting roadmap.
- Responsible for regular communication to project leadership & multi-functional team stakeholders.
- Assures all design & project work is completed in compliance with all regulatory requirements including, Quality (cGLP/GMP’s), EHS, Global Engineering, design & construction directives, requirements & procedures, as well as all Local/Federal Regulatory requirements.
- Supports the project manager on schedule and budget development and control.
- Development of the Data Historian and Reporting team resources for the project and other supporting vendors.
- Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- At least 6 years’ experience providing process control and information systems solutions.
- Experience directing system design, configuration and application of business processes in a biopharmaceutical manufacturing environment.
- Experience during project delivery and operations support of Data Historian and Reporting systems. Experience with the following systems is preferred; OSI-PI, PI-AF, RT Reports, Kepware, Factorytalk. Experience with process control systems would also be advantageous.
- Experience with designing information interfaces, data conversion, and network and infrastructure fundamentals.
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise.
- Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans.
- Working knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards. Thorough knowledge of Pharmaceutical Industry Regulations (cGMP/cGLP, OSHA, EPA/EQB) required.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Quanta are looking for System engineers for a large scale project in West Ireland. We are offering a 12 month contract, with flights and accommodation covered for the duration of your contract.
Quanta are looking for CSV engineers for a large scale project in West Ireland. We are offering a 12 month contract, with flights and accommodation covered for the duration of your contract. Being
Republic of Ireland
One of the top 10 best companies to work in Ireland is looking for more QA specialists for their large-scale new facility north of Dublin. Is this you? QA Specialist required to join a Global biotech
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