• Anywhere

Initial 12-month contract role with view to long term.

 Job Purpose:

Provide engineering support in developing new or improving existing equipment and/or process related activities. Define or assist in defining process equipment requirements and specifications based on process requirements, company safety requirements and customer needs. Supporting New Line installs / retrofits. Seeking relevant degree in production/manufacturing/mechanical engineering and previous experience in a GMP or medical device manufacturing environment with 3-5 years’ experience.

Responsibilities

  • Perform project management tasks for small to medium 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
  • Utilize 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
  • Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements
  • Ensure effective closure on quality system documents (Audit Action, NCR’s, CAPA’s, Maps, etc.)
  • Implementation of safety/environment requirements on purchase and changes of all new and existing equipment.

Education and Experience Required for Role

Essential:

  • Hold a relevant level 8 degree or equivalent qualification in production, manufacturing, or mechanical engineering.
  • 3~5yrs previous experience in GMP or medical device manufacturing environment.

Desirable

  • Prior experience in equipment and process validation activities
  • Process development experience
  • Familiar with ISO safety standards
  • Previous experience in the use of ‘black belt’ statistical techniques would be a distinct advantage, as would familiarity with equipment validation in a FDA environment
  • Have statistical process control and capability analysis using ANOVA and DOE techniques
  • Ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximize productivity and yields is an essential requirement.

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