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You will be part of the Operations Technical team and you will direct technical support functions to maintain and continuously improve equipment, process, and facilities.
In the initial phase, this position will have to assure that all the documentation and relevant processes and procedures are in place for a proper validation. Besides this, it will be responsible for ramping up the first lines, together with the maintenance area, assuring the correct output in terms of cost, quality and quantity.
It will also be accountable to set up the maintenance plans and spare parts for the new machines.
This position will have a natural evolution as the initial phases of the start-up are completed and new requirements become needed.
Major areas of accountability – ramp up phase
- Understand and learn about the technical processes and lines to be implemented in Portugal
- Participate in setting up the maintenance processes in the Portuguese site
- Define the correct spare parts and their stock level for the machines to receive
- Assure the correct level of documentation needed for the validation of the machines
- Assist and support the validation process of the first lines
- Assure the correct ramp up of the machines in the production phase
- Participate in the training of the maintenance technicians, assuring the proper knowledge transfer
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Major areas of accountability
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- Professional supervision of the equipment and machinery in the production area.
- Ensure the execution of scheduled maintenance activities.
- Responsible for planning of maintenance of assigned production machines.
- Responsible for keeping up to date the maintenance program on the ERP system (E1).
- Organization of technical trainings for other employees where required.
- Exploring and solving technical problems together with suppliers, technical staff, and operators.
- Analyzing and improvement of technical processes, production machines and equipment.
- Ensure to meet the required levels of Safety, Quality, Output and Cost.
- Installation, assembly & commissioning of production equipment and lines.
- Support technicians in discovering failures, quick and professional troubleshooting.
- Responsible for keeping up to date the maintenance program of the assigned production machines.
- Support validation tasks related to machines and processes: Maintenance, Operations Instruction, etc.
- Be the owner of Non-Conformities related with- the shop floor (NC´s) and CAPA
- Coordinate spare parts purchasing, defining minimum/reorder point for spare parts.
- Generate and follow-up of OR for spare parts, tools and other equipment required to run the machines.
- Generate work orders for parts to be produced in the Tool Shop
- Create and/or review documents in the document control system (Veeva)
- Act as the Subject Matter Expert for the production process under her/his responsibility
- Attend to meetings as required
- Willing to provide support to the escalations from production floor when needed on off-hours.
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Essential qualifications
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- Bachelor’s Degree in related Engineering field (e.g. Mechanical, Electromechanical, Mechatronics, Electrical, Chemical, Materials).
- 3-5 years of experience in engineering roles with responsibility in manufacturing processes.
- Ability to support high volume manufacturing operations.
- Computer skills (Microsoft Office Suite, ERP Systems)
- Good English knowledge
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Preferred qualifications
- Understanding of continuous improvement methodologies such Lean Manufacturing and Six Sigma.
- Desirable experience working in medical industries
- Working knowledge of design software such AutoDesk (AutoCad 2D, Inventor 3D, Vault database).
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfill their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.
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