Provide engineering support in developing new or improving existing equipment and/or process-related activities Primary Tasks and Responsibilities Define or assist in defining process equipment requirements and specifications based on process requirements, client safety requirements, and customer needs 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 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. Certification / Education Requirements. Relevant Engineering Degree or equivalent experience. Minimum of 2 years experience in a technical position. Technical leadership. Advanced technical degree. 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. Other Skills, Experience. Leadership skills. Proven technical skills. Ability to organise medium complexity technical issues. Ability to work effectively in a changing environment.
6 days ago