Collins McNicholas

Responsibilities;

  • Work collaboratively to drive a safe and compliant culture.
  • Coordinate the process improvement, equipment reliability and control system activities.
  • Identify, plan, schedule, manage and communicate on Technical equipment tasks/improvements to all affected stakeholders
  • Implement lean technologies for the Technical team activities such as standard work
  • Ensure that line processes, equipment and materials are maintained to deliver consistent, reliable and predictable process performance and product quality
  • Support the BU by developing robust process & systems to ensure delivery of effective quality
  • Support the BU in new equipment introduction by providing technical input to Project Teams and Documentation such as URS, FS,HDS,SDS etc.
  • Develop & implement systems & structure to minimise technical downtime on the line
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  • Resolve technical issues in an effective & timely manner with root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
  • Drive continuous improvement and process efficiency programs, i.e., OEE, OPEX, RCA, and productivity output for the BU
  • Manage external vendors and services for equipment and technology in the BU
  • Communication of any concerns about work processes to Management
  • Manage the technical documentation, reports, files, logs and records for the Technical Team
  • Assist with the trending, monitoring, performance of equipment and the reduction of unplanned downtime
  • Help manage, track and monitor the relevant KPIs for the Technical Team
  • Assist with the trending, monitoring and reduction of repeat deviations and alarms associated with the equipment and technology in the BU. Generate and approve associated change controls and relevant protocols.
  • Support the BU during regulatory and compliance audits.
  • 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

  • Third level qualification in Mechanical, Electrical or Process Engineering
  • Detailed knowledge of regulatory requirements in a pharmaceutical GxP environment.
  • Experience in high volume automation Pharmaceutical manufacturing environment.
  • Excellent documentation skills.
  • Ability to organize workload and work on own initiative
  • Experience: SAP, Coral, Quality software systems, working with Microsoft Office (Word, Excel, PowerPoint etc.).
  • Experience: +4 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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