Reference Code
DU19175

We currently have a vacancy for a Process Engineer (Small Equipment) for our client based in Co. Louth

We are currently seeking to recruit a Process Engineer to work via our OTS Department on a Greenfield Biologics plant based in Dundalk, Co. Louth.  The successful candidate will focus on the small-scale equipment element of the project.  We are looking for a Process Equipment SME to manage small equipment specifications and installations for the client project management team for a €325m Biologics Greenfield manufacturing facility. Reporting to the Process Equipment Manager, manage all the design and installation of small process equipment. Provide day-to-day support and coordination during the full cycle of design, build, and C&Q.

Role

Process Equipment Lead to work within their small equipment team for all buildings i.e. benchtop scales, freezers, fridges, desktop centrifuges, microscopes and weigh scales. This role will be responsible for the full life cycle of the project from concept to completion

Responsibilities

  • Liaison with the manufacturing, engineering, QC and QA functions in other sites to define the user’s requirement and transfer the knowledge to the engineering firm and vendors
  • Design, build, commissioning and qualification of manufacturing facilities and systems of biopharmaceutical therapeutics
  • Lead capital and non-capital projects and process engineering function insight into the equipment, processes and operations requirements
  • Establish technical support initiatives for GMP operations in a multi-product cell culture and purification facility
  • Lead cross-functional project teams to ensure specific unit operation requirements are implemented and tested in C&Q deliverables
  • Develop and/or review system lifecycle documents including C&Q documentation.
  • Manage installation / start-up / testing of process systems through OQ completion
  • Interface with cross-functional team to ensure systems’ post-OQ (PQ) readiness
  • Ensure all project stakeholders are informed and consulted on key process activities and decisions
  • Act as client representative to ensure that critical design deliverables are provided and provide direction & oversee design progression by Engineering Design Team
  • Ensure that all relevant engineering standards, procedures and best practices are followed
  • Ensure Design Risk Assessments and HAZOPs are performed

Qualifications & Experience

  • Chartered Engineer
  • Bachelor degree in Chemical or Process Engineering
  • 10+ years proven engineering experience with at least 8 years within the pharmaceutical, biotech, life sciences industries or engineering firm is required
  • Strong project management skills with good communications skills
  • Good time management skills and ability to work in fast pace environment
  • Hands-on experience in process equipment for the biotech industry
  • Familiar with safety rules and regulations as per national and other applicable agencies, such as FDA, EMA and HPR

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Do you have what it takes ?

Process Engineer - Small Equipment - DU19175

Dundalk, Co Louth, Ireland

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