R.T.Lane Recruitment is looking for a Labelling Engineer to join Quality Operations Engineering Team. Successful candidate will be responsible for the validation, change management, in process monitoring and maintenance of the Sterile Barrier packaging process lines located in the ISO7 cleanroom environment.
Must have experience of Label Software Systems in Regualted enviornemnt either Pharmaceutical or Medical Devices.
- Build a Label & Packaging Excellence Program within the Device Manufacturing group.
- Identify all packaging requirements, establish guidelines for success and train/mentor teams through the packaging process with a view to improving the overall in-house awareness of the key principles and standards.
- Manage relations with vendors and external service providers to ensure a consistent approach across projects, including validation and appraisal of packaging suppliers – (equipment and material).
- Support Device Manufacturing on various projects in terms of package system design and implementation. Develop project plans with aggressive and achievable milestones.
- Develop complete packaging concepts and specifications, and improve existing configurations to ensure the quality of the packaging process and product.
- Interface with the Quality Assurance and Regulatory departments to provide packaging input to product submissions and demonstrate a good understanding of Medical Devices labelling regulatory requirements.
- Communicate and participate in packaging related troubleshooting projects, support new product introduction and be the main point of contact and support for internal and external audits/inspections.
- Design, test, and implement integrated automated inspection for all product lines and apply control/security management to the label printing system.
- Provide printer and labelling support for issues observed in manufacturing and demonstrate systematic problem-solving expertise to resolve.
- Partner with cross functional teams as the packaging and labelling expert, and represent the team at department level.
- Knowledge of Barcoding systems and UDI requirements. Knowledge of GS1 and HIBCC identification.
- Experience of label printing applications and ERP systems such as BarTender and SAP.
- Proven track record in packaging and print material design and implementation.
- Strong communication skills with both internal and external customers.
- Project management skills and excellent attention to detail required.
- Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment
Education and Experience
- Level 8 degree in Engineering / Packaging Technology or equivalent.
- At least 2 years’ experience within a packaging/labelling design or process environment in a regulated environment such as Pharma / Medical Devices.