Project Engineer (Senior)

Competitive
Contract
Limerick
11 Mar 2019
BBBH698967

12 Month Contract role for a Senior Project Engineer, to provide technical leadership in a GMP manufacturing environment

The successful candidate will take ownership for the successful installation and validation of a manufacturing cell. This will include the identification and spec'ing of the required equipment. Liaising with vendors to ensure requirements are met and schedules are maintained. The creation and approval of FAT and SAT documentation associated with their assigned cell. Development of an installation schedule and execution of the SAT testing once the equipment is installed.

Key Responsibilities:

  • Define or assist in defining process equipment requirements and specifications based on process requirements, safety requirements and customer needs
  • Perform project management tasks for medium to large scale projects involving either new or existing equipment
  • Assist in determining the budget to support requirements
  • Evaluate or assist in evaluating technology necessary to support requirements
  • Propose options to Management/Customer/Stakeholders
  • Provide technical support for projects
  • Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes and procedures
  • Assist in negotiation with equipment suppliers
  • Utilise necessary project tools, i.e. URS, Microsoft Project, etc. to manage projects successfully
  • Develop the necessary equipment, process and product knowledge to be recognised as a local expert
  • Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements
  • Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs
  • Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes

Qualification and Experience required:

  • Relevant Engineering Degree or equivalent experience
  • Minimum of 1 years' experience in a technical position
  • Technical leadership
  • Prior experience in a GMP or medical device manufacturing environment
  • Prior experience in equipment and process validation activities
  • Process development experience
  • Equipment conceptual skills
  • Experience of bespoke capital equipment
  • Ability to organise medium complexity technical issues
  • Knowledge of relevant safety standards
  • Knowledge of equipment and process validation and documentation procedures and processes

Morgan McKinley is acting as an Employment Business in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

Juanita Vosloo's picture
Consultant | Engineering Contract Recruitment | Nationwide
Cork, Dublin, Limerick, Waterford 061 430 940 | jvosloo@morganmckinley.ie