Maintenance Method Engineer
Job Summary (Primary function)
Within the Engineering department of Incyte's biotechnology production site in Yverdon-les-Bains, the Methods Engineer is responsible for harmonising the compliance processes of the Engineering department and provides essential support to the maintenance activities, in charge of carrying out the management activities of the production equipment and technical installations.
Essential Functions of the Job (Key responsibilities)
- Harmonize the maintenance processes and procedures of the site.
- Actively support the handling of non-conformities on maintenance activities and change management.
- Harmonize processes and support the writing of GMP records (Change control, Deviations, Technical investigations, Preventive and corrective actions).
- Administer the existing CMMS system and keep it up to date (spare parts stock management, maintenance plans, bills of material and maintenance ranges).
- Support the implementation of a new CMMS software and more specifically set up the equipment and spare parts database of the site.
- Consolidate and maintain all maintenance and metrology SOPs for the site.
- Lead the continuous improvement of the site's maintenance systems and processes.
- Ensure that procedures, technical records of equipment and systems under your responsibility are up to date at all times.
- Ensure that the ASIT and electrical concept files for the site are kept up to date in collaboration with the maintenance manager.
- Ensure the follow-up of required updates of the existing site layouts with the support of CAD responsible.
- Keep up to date with the evolution of the applicable standards related to the activities of the Maintenance department.
- Set up performance indicators for the Engineering department (Maintenance, Metrology, Automation, Project Management Office). Follow up these indicators, identify improvement actions and lead their implementation.
- Carry out all tasks necessary for the proper functioning of the maintenance and metrology department.
- Apply and enforce when necessary the safety guidelines (EHS).
- Contribute positively to a strong culture of integrity and business ethics.
- Act in accordance with legal and compliance requirements and company guidelines.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Engineering educational background in a technical field (process engineering, mechanical engineering, industrial chemistry, biotechnological or equivalent).
- Minimum 5 years’ experience in a pharma/biotech GMP production environment.
- Good knowledge of GMP and familiar with quality processes (change management, deviation, investigation and CAPA), and of the main biotech production equipment (bioreactors, chromatography columns, etc.), Utilities and HVAC.
- Knowledge of Swiss standards (ASIT, NIBT etc...).
- Good interpersonal and communication skills to maintain a positive team spirit.
- Mastery of continuous improvement processes (SMED, 5S, Lean).
- Expertise in maintenance methods.
- Knowledge of basic energy balances for a production site.
- Good knowledge of Environment, Health and Safety (EHS).
- Good knowledge of MS Office (Excel, Power Point).
- Good knowledge of CMMS (Maximo, SAP is a plus).
- Knowledge of basic production management (SMED, 5S, Lean).
- Analytical skills, proactivity, sense of priorities, flexible and versatile, excellent communication skills, and resistance to stress, rigorous, methodical and have an analytical mind.
- French and English (good oral and written skills).