Labelling Engineer II
Job ID: JOB-13198
Title: Labelling Engineer II
Duration: 12 month contract
Ensures the efficient operation of the Product Labelling function, working with internal and external stakeholders to ensure that all Product Labelling requirements are met in line with Global Labelling Standards and Procedures.
- Responsible for the final review and co-ordination of labelling activities for all product labelling into the production environment.
- Ensures effective planning and management of timelines for all aspects labelling and control of release into the production environment.
- Decisive, self-motivated/capable of working on own initiative, and able to prioritize and a proactive approach.
- Assist in review and Windchill change notice activities for the approval and release of other packaging components i.e. DFUs, Cartons, Pouches.
- Monitor and ensure compliance with local and Corp policies and procedures.
- Create, review and maintain curriculums associated with GLS (Global Labelling System) and associated processes.
- Work independently to schedule and complete activities necessary to meet projects & production timelines.
- Provide day to day GLS system support to all established Production lines and NPI (New Product Introduction) Projects.
- Develop, maintain and enhance relationships with the clients global counterparts in Packaging/Labelling, Marketing, Regulatory and Quality functions.
- Demonstrated ability to identify and work with cross functional organizations to implement label designs, packaging components and in the problem solving of labelling & packaging related issues as required.
- Participate in global packaging and labelling projects, to ensure Cork is at the fore front and is involved in any testing/proposed changes on both existing and new products.
- Familiarization with Medical Device labelling to 21 CFR 801 an advantage.
- Establishes and supports a work environment of continuous improvement that supports the client’s Quality policy, Quality System & the appropriate regulations for the area.
- Support relevant non-conforming event and corrective and preventive action (CAPA) monitoring progress where applicable and drive through to completion for all action items pertaining to label issues, including problem solving to resolution, root cause analysis and implementation of corrective item.
- Communicate to teams and management on the progress of labelling related projects.
- Represent the site as audit facing SME for Product Labelling and the associated Global & local processes & procedures.
- Ensure audit readiness at all times and participate in Incident Review Board meetings on a quarterly basis.
- Understanding of the clients packaging and labelling processes and how they fit into the overall product deliverables in line with the NPI process.
- Knowledge of Change Control Systems, Bill of Materials, Preventive & Corrective Action systems, Labelling Management systems etc. Knowledge of Windchill, MES, SAP, eCapa, Prisym applications an advantage.
- Excellent written and verbal communication skills, with a high level of attention to detail.
- Strong command of MS Office – Word, Excel, Visio, PowerPoint.
- Knowledge of EU MDR requirements is an advantage.
- Experience in the medical device industry is an advantage.
Quality System Requirements:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the clients Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Job Scope and Levelling Guidelines:
An experienced professional with a complete understanding and wide application of principle, theories, and concepts applicable to a labelling system. Applies a full understanding of area of specialization to resolve a wide range of issues. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships.
Planning and Organization:
Plans, organizes, and prioritizes own daily work routine to meet established schedule. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
Develops solutions to a variety of problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
Discretion/Latitude; Supervision Received; Decision Making:
Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to local and company policies.
Consequence of Errors:
If errors on final label design, or packaging component are printed/used in the production environment, escape the clients controls and into distribution to customers, there is a high possibility of a recall.
Business Relationships and Project Management:
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
Operations Involvement/Direct Work Involvement:
Investigates and solves problems that impact work processes and personnel within a unit or department.
May participate in various department project teams.
Ensures that projects are completed on time following established procedures and schedules. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources.
Influence and Leadership:
Promotes department goals by selecting, motivating, and training capable staff. Leads the activities of assigned staff by communicating and providing guidance towards achieving department objectives.
Participates in the development of less experienced staff in labelling department or external department by setting an example, providing guidance, and offering counsel.
For further information on this role in Cork please contact Sinead Killalea on email@example.com or 086-1287246
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