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 Cork site:
The Production Engineer is the responsible for the management of Production Processes on site; for managing and supporting the established Products, including Process improvements; and actively leading new product introduction: from other manufacturing facilities and scale up from Lab.
Process Engineer (M/F)
- Responsible for the day to day running of API or Spray Drying processes, trouble shooting and meeting production schedules;
- Ensures yield and quality targets are met;
- Leads and supports the production teams to achieve the manufacturing goals;
- Forecasts operational requirements/ resources based on future production schedules, projects etc. so as to ensure the production targets are met;
- Initiates and leads cross functional team investigations for yield and quality issues;
- Ensures comprehensive follow up and corrective/ preventive actions are in place for Quality and Safety deviations;
- Is the Lead person for New Product introduction;
- This involves designing, implementing and supporting new processes in conjunction with Quality, Safety, Engineering and Technical Services;
- Provides technical support and direction to production supervisors and operators;
- Is responsible for producing production documentation for new and existing processes, such as Batch Production Records, cleaning documents, URS, etc. Initiating and leading technical transfer activities for the introduction of new products utilizing best available technology, practices and tools as appropriate;
- These include the use of Six Sigma, FMEA, Lean Manufacturing, Risk Assessment, Quality by Design, etc. Liaises with all functions to ensure process execution through cross functional influencing;
- Is responsible for process improvement, such as cycle time improvement, usage of utilities, cost reduction, increase in yield, minimizing waste, etc.;
- PLeads production related processes on site in compliance with all relevant legislation and regulatory standards including H&S, Environmental and Quality;
- Drives continuous improvement initiatives across the plant in areas of Quality, Safety, Cost and People;
- Works in conjunction with Quality to ensure Product Quality and compliance with the Quality system at all times. Evaluates in conjunction with the Health & Safety team new equipment/ processes/ chemicals for introduction using tools such as HAZOP, Risk Assessment, What if, etc. Initiates and documents change controls as appropriate;
- Ensures that all the production documentation is completed in accordance with cGMP;
- Presents a written monthly report to the Operations Director providing details on agreed KPI's and metrics;
- Other duties as required by the Manufacturing Director in keeping with the nature of the role.
- BSc / BEng, Msc / MEng in Chemical Engineering or equivalent;
- 3-7 years of industry API experience working within the pharmaceutical industry;
- Experience in technical manufacturing support;
- Experience in equipment and technology design, selection and testing;
- Tech transfer, capital project support, and start-up experience of multiple processes from early stage development to commercial scale;
- Experience in Production operations, trouble shooting and creative problem solving within a technical environment;
- Current knowledge of GMP regulatory requirements in US and EU;
- Excellent written and verbal communication skills;
- Excellent problem solving skills;
- Ability to interact with and be part of multi-disciplinary teams;
- Experience in Delta V systems a distinct advantage.
- 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.