Expert in pharmaceutical processes and quality
What is a Master of Science (Pharmacy) doing in an engineering agency, one might wonder upon hearing that Heikki Niskanen, known for his work at Galilaeus and Orion, is currently employed by Elomatic. But he is at exactly the right place. The engineering company’s broad range of services also include comprehensive factory projects in which the client may be a pharmaceutical company.
Heikki Niskanen, M.Sc. (Pharmacy), works as a Senior Consulting Engineer in Elomatic Mechanical Oy, a subsidiary of Elomatic Group, which delivered, for example, a turnkey infusion plant to Turkmenistan in 2013. Similar projects are being developed all the time, so Mr Niskanen’s expertise comes in useful. He has thorough knowledge on and competence required by the law on the quality requirements of pharmaceutical production, as well as practical experience in planning the production and quality assurance systems.
Diverse and comprehensive work
Mr Niskanen is very enthusiastic about his job and has got a good hold of it after 18 months.
”This is very interesting. Elomatic operates globally and we make offers on different kinds of projects. We aim at overall service that combines different functions of the company, such as process planning, product development, information technology, project management and investment planning. In fact, the process operations are bigger than the better-known marine and offshore operations, and we have many more specialised operations. For example, the Tampere unit has designed a cardiac valve coil, and the Jyväskylä unit specialises in the visualisation of processes and premises, so that ergonomics can be dimensioned and illustrated according to the dimensions and wishes of the users. In terms of cost-efficiency, it’s important to optimise the use of space and the placement of commodities, such as pipes. 3D software is a useful tool which we use in our own designing, but we also sell the software to our clients”, Mr Niskanen says.
From a client to a salesman
Mr Niskanen is now sitting on the other side of the table. Now the pharmaceutical companies are his clients.
“The work is very diversified. We need to manage both the big picture and details. It all starts with concept design which is followed by the actual design and mapping of suppliers. The last phase deals with the details; for example, the planning of a laboratory with exact location of the equipment. I also participate in offer calculations and equipment purchasing.”
The available projects are very different from each other and acquiring them is slow, because the competition is tight and investments are considered carefully. It may take as long as a year and a half from the offer to delivery, because there is a lot of planning involved and the delivery times of some equipment are long.
“Sometimes a pharmaceutical plant requests just an audit. I can map out the operations of the plant and give recommendations e.g. for manufacturing or quality functions or for an upcoming expansion. Some projects keep growing while in progress, when the client notices that they don’t master all aspects after all”, Mr Niskanen explains.
Russians aim at the European markets via Finland
Heikki Niskanen benefits from thorough knowledge of the industry and his contact network created over the years and the fact that Finland was among the first countries in Europe to introduce the EU’s new quality assurance practices (GMP) for pharmaceutical products. He already has plenty of practical experience in them, while some countries are still only thinking of putting them into practice.
”At present, Russia in particular is working actively for the pharmaceutical quality issues, because they want to switch quickly to the new GMP system (EU GMP) and use it to expand their markets to Europe. They can access the European markets via Finland, and we have had some projects in St. Petersburg and Lappeenranta. We have implemented projects in Sweden for a long time, but we also get a surprisingly high number of enquiries from outside Europe, for example the Middle East and India. We have our own offices in St. Petersburg and India.”
Variation at work
Heikki Niskanen’s career has proceeded in 12-year cycles. He spent the first cycle in product development at Farmos which soon became part of Orion. Then he worked for another twelve years in biomedicine development company Galilaeus in Kaarina. In the small company Mr Niskanen had a large area of responsibility.
“We set up an entire GMP system, or the manufacturing and quality assurance system required from pharmaceutical plants, in order to start our own production. I was also involved in starting up the GMP at our plant in Poland. In addition, I was responsible for the quality issues at the plant and the release of drug batches for retail.”
Over the years, Heikki Niskanen has occasionally worked as the head dispenser in pharmacies and in another biomedicine development company as the QP who releases test drug batches for clinical deliveries.
As a counter-balance to his responsible work Mr Niskanen exercises and still plays tennis with his old colleagues from Farmos. Born in Kajaani, he came to work in Turku via Jyväskylä and Kuopio and has found his place here.
“The sea is a fascinating element, although I don’t own a boat. We have a summer cottage in Nauvo, and my older son is a Sea Scout. The younger one plays football.”
- Senior Consulting Engineer, Elomatic Mechanical Oy
- Born in Kajaani in 1962
- Lives in Turku
Master of Science (Pharmacy), University of East Finland, Kuopio,
Qualified Person (QP), EU’s statutory qualification for releasing medicinal products for sale
- 2013– Senior Consulting Engineer, Elomatic Oy, Turku
- 2001–2012 Quality Director, Galilaeus Oy, Kaarina
- 2006–2010 Head Dispenser, Turun Kauppatorin Apteekki pharmacy
- 2004–2005 Qualified Person (QP), Novatreat Oy, Turku
- 1988–2001 Researcher/product development, Orion Pharma (previously Farmos Oy), Turku
- 1989–1991 Director, Bristol-Myers Oy, Turku (product releases)
- Family: Wife and two sons (aged 13 and 17)
- Hobbies: Volleyball, tennis and other physical exercise, summer cottage
- Consulting and engineering company based in Turku, founded in 1970
- Five offices in Finland, two in Poland, and one office in each: Russia, Serbia and India
- Turnover 52 million euro (2013), around 700 employees, clients in 70 countries
- Provides comprehensive services for plant, ship and mechanical design and project management
- Business areas: Marine & Offshore, Mechanical, Process & Energy, Cadmatic Software
- Pioneer in the development of 3D designing software
Text and photos: Anne Kortela