Description:
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, client's safety requirements and customer needs.
Key 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.
Qualifications & Requirements:
- Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering.
- 4 years’ experience in relevant engineering role
- Prior experience in a GMP or medical device manufacturing environment
- 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.