Collins McNicholas

Responsibilities:

  • Provide technical support to high speed automated production and utility equipment
  • Assess business risk to the Business Unit from system failures, create recovery plans and projects to address
  • Manage the Inventory and lifecycle of computer/control systems within their respective business units
  • Backup/Archive of data and software on control systems, along with disaster recovery of PLC’s, HMI’s and PC’s
  • Manage and drive software / data integrity requirements for the Business Unit. Identify gaps and implement fixes
  • Work with Equipment manager, supervisors, managers to prioritise work and work with Business Unit members to ensure the target closure dates are achieved
  • Lead and provide feedback to project owners on the status of automation, PLC backup, HMI and data integrity projects in the Business Unit
  • Support production during audits of automation, PLC back up and data integrity
  • Support the generation and routing of data integrity and system based documents through the Quality Assurance process
  • Support new equipment installations in a busy production environment
  • Take a pro-active approach to resolving any unexpected technical difficulties that may arise.
  • High level of input into DFMEA & PFMEAs for facility, equipment and process
  • Challenge of Design documentation to meet QA, OPEX and EHS requirements (URS, ES, DS, SDS, HDS, FSDS, RTM, DQ, Pre-FAT, FAT, SAT). Vendor site visits
  • Review, approval & execution of validation activity to meet QA, OPEX and EHS requirements (IQ/OQ/PQ/PPQ)
  • Attend Tier meetings
  • Attend external meetings as required
  • Attend 1:1 meeting with manager

Education and Experience

  • The successful candidate will have Level 6 or level 7 HETAC qualification in Mechatronic/Automation
  • Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment
  • Experience in high volume automation / robotics Pharmaceutical manufacturing environment
  • Experience in Pneumatics, Electronics, Hydraulics, Programmable Controllers, Servo Motor drives, Vision and SCADA systems
  • Experience of field-bus protocols (Ethernet/IP, Modbus, Profinet), PLC – Siemens, Allen Bradley
  • Excellent documentation skills.
  • Ability to organize work load and work on own initiative.
  • Experience: SAP, Coral, Quality software systems, working with Microsoft Office (Word, Excel, PowerPoint etc.).
  • Experience: +3 years working in a regulated environment.
  • Experience of working on a team, including strong organisational and time management skills.
  • Strong ability to evaluate, diagnose and troubleshoot problems.
  • Flexibility to respond to issues outside normal business hours.
  • Ability to learn new and different technologies

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