Data Historian Senior Engineer
CK Group is recruiting for a Data Historian Senior Engineer to join a company in the Pharmaceutical industry at their site based in Ballydine on a contract basis for 11 months and has an hourly rate of €48.96.
The Company: Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. This position sits within their Manufacturing Division, which consists of a team of dedicated, energetic individuals, committed to being the most trusted supplier of pharmaceuticals and health products worldwide. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Location: This role will be working at the Ballydine site which exports to more than 30 countries, including Japan, the US and much of Europe. It produces active pharmaceutical ingredients (APIs) for use by subsidiaries throughout the world, including late stage clinical APIs. The site includes a formulation, R&D and manufacturing facility, which supports clients initiative to bring new medicines to market more effectively. It develops innovative ways to formulate new products from pilot to commercial scale, and supplies tablets for late stage clinical trials, launch and early stage supply.
The Role: 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 ensuing adherence to the QAPs.
Key duties include: 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 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.
- 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.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46745 in all correspondence.