Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Loures site:
Qualification Engineer (M/F)
The Qualification Engineer will be responsible for:
- Assuring that process systems and/or equipment are designed, installed and commissioned as per Good Engineering Practices (GEPs);
- Performing the qualification of process systems and/or equipment as per Good Manufacturing Practices (cGMPs);
- Assuring the cGMP compliance of the process systems and/or equipment.
- Manage of Equipment and Facilities Qyualification process related activities;
- Perform Validation and Qualification assessment in the scope change controls;
- Quality Systems Management (DocStream; CAPA; Changestream);
- Participate of Client and/or Health Authorities audits in the scope of
- Qualification and Validation matters;
- Assure and promote compliance of the Health, Safety Environment (HSE) program applicable to the area and activities for wich is responsible or in wich it participates;
- Assure compliance of personal objectives and KPI's;
- Promote a continuous improvement culture.
- University degree in Engineering area Chemical, Mechanical, Electrical or equivalent degree in a scientific area;
- Preferably 3 years of experience in the Pharmaceutical Industry;
- Preferably 6 months relevant experience performing Equipment Qualification;
- Good general knowledge om Quality, cGxPs, ICH, ISPE and ISO guidelines as well as experience on their application;
- Knowlegde of risk assessment methodology approach applied to Validation and Qualification;
- Ability to discuss technical aspects within Design Review meetings scope or with clients and suppliers (i.e. within the scope of audists);
- English fluency (written and oral);
- Good technical and analytical skills;
- Good communication skills;
- Critical and proactive personality;
- Rigor and responsability;
- Iniciative and dynamism.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.