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Process Engineer

Reference ID : 01918MQ
Category :
  • Pharma / Biotech
Date Posted : Jun 19, 2020
Job Location
:
  • Dublin
Experience :
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking 3 Project Engineers for an expansion project at our client’s biotech facility.

Principal Responsibilities

Projects Engineers x3

These candidates will be required to work closely with a cross-functional team and coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT and QA.

They will provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility.

Responsibilities:

  • Assist in the development and delivery, within the overall project schedule, of a schedule for the delivery of all aspects of the Suite scope.
  • Develop, document, agree and implement an execution strategy to deliver the scope in a controlled and well communicated manner.
  • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
  • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
  • Support installation / start-up / testing of process systems through OQ completion.  Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Provide coordination expertise during C&Q activities as needed.
  • Assist in the coordinating of C&Q start-up activities, punch list follow-up.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation).
  • Delivery of the agreed milestones on the schedule within budget constraints.
  • Delivery of stakeholder agreed scope for Suite facilities to Commissioning Qualification or as appropriate Process Qualifications.

 


Qualifications & Requirements

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 6 years’ experience similar role in Pharmaceutical Facility/ Building/Utilities systems within Pharmaceutical industry.
  • Working knowledge of standards as they apply in biotechnology processes industries and a working knowledge of FDA and EU regulations is preferred.
  • Experience of design and construction/handover of pharmaceutical process and building facilities for pharmaceutical facilities.
  • Ability to work in design and construction large project environment within Ireland.
  • The candidate will be a convincing communicator with strong interpersonal skills
  • Working knowledge of control systems and automation.
  • Working knowledge of C&Q documentation required for cGMP project delivery.

For further information please contact Mick on 086-0435195 or forward details in confidence to jobs@headount.ie




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