• 12 Month Contract
  • Limerick

Project Engineer Contractor

Industry : Pharmaceutical

Role Summary:

Designs, specifies and commissions new and renovated biopharmaceutical process equipment.
Provides engineering support and problem solving for existing equipment and manufacturing processes.

Role Duties and Responsibilities:

Duties and responsibilities include, but are not limited to, the following:

  • Managing and coordinating contractors ranging from civil, mechanical, electrical, and automation.
  • Strong knowledge in safe working procedures.
  • Managing all aspects of project financial control.
  • Ability to report project status and align with aggressive timelines.
  • Designs and specifies cGMP process equipment, piping, and controls.
  • Scope and update functional Design Specifications (FDS) for automation updates on process equipment.
  • Manages small-to-mid sized projects related to process equipment and manufacturing. Types of equipment exposed to are as follows: WFI, CIP, Bioreactors, Centrifuges, Chromatography, Media Prep, Buffer Prep and UFDF.
  • Assists in the design review, site acceptance and installation of equipment.
  • Updates piping and instrumentation diagrams (P&ID) and other related drawings.
  • Updates Process Flow Diagrams for manufacturing processes.
  • Supports QA Validation department by preparation of design documents and assists in protocol execution.
  • Assists in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Identifies & implements corrective/preventative actions (CAPAs) for existing qualified GMP equipment and manufacturing processes through site change control process.
  • Identifies & implements process improvements for manufacturing processes and utilities.
  • Prepares engineering evaluations and test plans for and executes change control documentation.
  • Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Assists with tech transfer activities, such as process scale up and New Product Introductions (NPIs).

Education and Experience:

  • Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 – 5 years related experience.
  • Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education.
  • GMP and GDP experience would be desirable.

Contract Duration:  12 month contract with hybrid working.

Location:  Limerick

To apply for this job email your details to enquiries@qaresources.com.