OEM Engineer
OEM Engineer
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Job Description
Horizon Controls Group are hiring for an OEM Engineer for one of our clients in the Leinster area.
Participate in the development review and approval of project SDLC documentation and deliverables.
Integrate OEM systems with site DCS (DeltaV) and SFN subsystems (PM Server Octoplant Simatic Logon time sync. etc) ensuring compatibility and functionality.
Execute validation and qualification automation test protocols (EIOC AIOQ ACP) to ensure the reliability and compliance of integrated systems.
Serve as a subject matter expert (SME) in Siemens S7 PLC and HMI systems providing guidance and support to project teams.
Offer technical assistance to CSV & DDQ teams ensuring adherence to regulatory requirements and industry standards.
Provide ongoing technical support to Manufacturing Operations troubleshooting issues and optimizing system performance.
Collaborate with crossfunctional teams to identify opportunities for process improvement and innovation.
Stay abreast of industry trends technologies and best practices to continuously enhance knowledge and skills.
Qualifications:
Bachelors degree in Engineering Computer Science or related field.
5 years of experience in a similar role preferably in a GMP regulated environment.
Proficiency in Siemens S7 PLC and HMI systems with demonstrated expertise in integration and troubleshooting.
Experience with DeltaV PAS and other relevant subsystems.
Strong understanding of project SDLC processes and documentation.
Experience with validation and qualification of automation systems.
Knowledge of regulatory requirements such as FDA GMP and GAMP.
Excellent communication skills with the ability to effectively collaborate with crossfunctional teams.
Detailoriented with strong problemsolving abilities.
Ability to work independently and manage multiple priorities in a dynamic environment.
Familiarity with CSV (Computer System Validation) and DDQ (Data Integrity and Data Quality) processes.
Horizon Controls Group have an exciting opening for a CSV Engineer with one of our major clients in the pharma industry. The successful candidate will join the DDQ team on a site re-structuring project to provide independent compliance oversight and support for the implementation of new shopfloor automation systems and modifications to existing site systems. The DDQ specialist will ensure compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. The DDQ specialist will support a number of shopfloor system, including, DeltaV DCS systems, PLC/SCADA systems and other manufacturing systems. Responsibilities: Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, protocols and reports for new and modified systems. Providing independent quality review and approval of system changes. Supporting and approving computerised systems investigations and test deviations. Ensuring consistent approach to qualification, change and deviation management across systems being implemented on the project. Providing timely and pro-active DDQ support and guidance to facilitate project timelines, including close collaboration with the technical and business units. Where required, engaging with DDQ teams from other sites and capital projects to standardise and align approach to computerised systems compliance. Experience: Min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry. Working knowledge of relevant regulations and industry standards. Proven ability to meet timelines, prioritise tasks and engage with stakeholders. Excellent communication skills. Project management experience will be an advantage. DeltaV DCS experience essential.
Employment Type
Full Time
