R.T. Lane Recruitment
Initial 12 month contract role.
You will 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, company 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.
- 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.
Education and experience
- Level 8 degree in production, manufacturing, or mechanical engineering.
- Minimum of 4yrs previous experience in a relevant engineering role within a regulated manufacturing environment.
- Prior experience in equipment and process validation activities.
- Process development experience Equipment conceptual skills.
- Experience of bespoke capital equipment.
- 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 an FDA environment.
- Have statistical process control and capability analysis using ANOVA and DOE techniques