Reference Code
DU19110

We require an experienced Senior Process Equipment Lead for our Client’s Project Management Team, based in Co. Louth.

Responsibilities

  • Support process equipment installation and control systems used in the manufacture of biopharmaceuticals
  • Provide on the floor operational support as needed
  • Support the design and qualification of improvements, changes, or upgrades in production equipment as needed
  • Support the development of design and start up documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
  • 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
  • Support the development of validation and qualification documents
  • Provide the execution of commissioning and qualification activities
  • Support the maintenance department as needed
  • Provide equipment maintenance history review
  • 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
  • Support investigations, audits and quality systems as needed
  • Support tech transfer and changeover for commercial and clinical processes as needed

 

Requirements

  • Minimum of 10+ years in similar type role ideally within a biotech facility
  • Bachelor degree in Engineering in relevant discipline
  • Previous experience working on large complex projects
  • 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

Please Note

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

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Senior Process Equipment Lead DU19110 - DU19110

Louth, Ireland

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