CSV Engineer

Horizon Controls Group Cork have a fantastic opportunity for an Automation CSV Engineer providing Projects and Run the Business (RtB) CSV support.

Project responsibilities include managing electronic Life Cycle documents for GMP SCADA/PLC & BMS systems changes/upgrades. Lifecycle Administration Change Control activities and dealing with Global IT organisations to complete IT risk assessments and raise IT requests on ServiceNow platform to implement server / PC changes.

This position will be responsible for managing Computer System Inventory (ServiceNow) authoring and updating Admin Procedures Periodic Review Reports User Access Reviews Automation Change protocols for system bugfixes.

The CSV Engineer is responsible for activities that include the following:

• Generating reviewing and updating life cycle documentation including RS QAP FDS RTM FAT SAT IOQ QASR and Administration/Disaster Recovery SOPs Periodic Review Reports (PRRs)
  
• Generating and administrating Automation Change Controls for GMP systems
  
• Power User on Electronic Document Management Systems MEDS eVal/Kneat VeevaVault/Quality Docs for Change Control Incident Management Life Cycle documents SOPs System Inventory Management
  
• Coordination with System Integrators on Vendor supplied test documents
  
• Interact with Global IT organisations to complete IT risk assessments raise IT tickets for server / PC / Firewall changes etc.
  
• Compliance SME 21CFR11 Data Integrity Change Control Life Cycle documents.
  

Required skills and experience:

• Qualification in Engineering Computer Science or other technical degree.
  
• 35 years pharmaceutical site experience.
  
• Understanding and practical experience of cGMPs and SDLC CSV.
  
• Excellent ability and willingness to learn and take ownership Projects & RtB CSV deliverables.
  

Good to have it:

• Experience with MEDs ServiceNow and Remedy applications.
  
• Experience with SCADA & BMS Shop Floor systems consisting of Thin/FAT Clients application/IO/ SQL database server architecture.
  
• Experience in KNEAT is a big advantage
  

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

General Information:

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties responsibilities and skills required of personnel so classified.

The incumbent must be able to work in a fastpaced environment with demonstrated ability to juggle and prioritise multiple competing tasks and demands.

If you are interested in the above position please contact Madlen Nikolova in Horizon Controls Group on.