Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures, and services.
We are currently looking for Automation Project Engineers for one of our client sites on a Cork based site. We require this person to be responsible for end-to-end delivery of Control System upgrades and new installations.
Experience Required:
* Min 5 years’ experience within the life Science sector in in project delivery.
* Excellent understanding of cGMP's, SDLC methodologies and LEAN/MPS/ Sigma principles. Excellent facilitation, problem solving, and decision-making skills.
* Demonstrated ability in Project Management.
* Ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
* The following experience is desirable Project experience with Kneat E-validation, Enablon Management of Change, Siemens PLCs and HMIs, Intouch Wonderware SCADA, Siemens Desigo BMS, Life Safety systems, SQL, Thin/Fat Client Application / IO / database server architecture, OSI PI, 21CFR11 compliance, Data Integrity.
* Automation Project execution at a GMP manufacturing site.
Required Qualification: Science, Engineering or Technical Degree qualification.
Main Responsibilities:
* Concept studies and costing.
* Change Management process.
* Track Project deliverables and manage budget.
* Develop and manage Project schedules.
* Coordinate stakeholders, vendors, and contractors during project delivery.
* Develop automation scope of works (URS) in conjunction with the System Owner.
* Scope and requisition of supporting site IT infrastructure in conjunction with the IT team (Virtual Servers, IT switches etc.).
* Engage the system integrator.
* Manage offsite/onsite automation works (Development, FAT testing, installation, shakedown, SAT & User Acceptance testing).
* Develop/review/execute/approve E-Validation Lifecycle documentation (RS, FDS, RTM, QAP, QASR, FAT, SAT, UAT/IOQ).
* SME for MSD standards as they relate to Automation Projects SDLC, validation, hardware, software environments and business processes.
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