Manufacturing Shift Engineer

Nerdgigs

Dunboyne, County Meath, Ireland
Onsite
Process engineering systems
Real-time process monitoring
Deviation investigations sme
The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance, being the main point of contact for real-time process monitoring and troubleshooting

Job Summary

  • The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance, being the main point of contact for real-time process monitoring and troubleshooting.
  • The role will involve being a key point of contact and liaison between Manufacturing Operations and Manufacturing Technical Support, working as part of a team of scientists, engineers and support specialists who will be responsible for supporting routine batch activities and transform the business initiatives.
  • Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of significant technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response-to questions, health authority inspection SME support, and more.

Matching Summary

The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance, being the main point of contact for real-time process monitoring and troubleshooting.

Skills & Requirements

Must-have

  • Process Engineering Systems
  • Real-time Process Monitoring
  • Deviation Investigations SME
  • cGMP Guidelines
  • Electronic Batch Records
  • Process Optimization

Nice-to-have

  • Collaboration and Negotiation Skills
  • Cross-functional Team Leadership
  • Continuous Improvement Initiatives
  • Interfacing with Regulators

Key Requirements

  • Minimum Level 8 qualification or equivalent industrial experience
  • 3-5 years experience in regulated pharmaceutical manufacturing
  • Demonstrated knowledge of continuous improvement methodologies
  • Demonstrated collaboration, negotiation & conflict resolution skills
  • Exceptional analytical, problem solving & root-cause analysis skills

Work Rights

Not specified

Tailored Resume

Cover Letter