In October 2019, Dermot Dineen began a contract role as a senior commissioning, qualification and validation (CQV) engineer at a large biopharmaceutical company in Sweden. This was his first experience of working overseas, he writes, and despite the challenges of the COVID-19 pandemic, 'I am happy to say that it was not my last as I pursued subsequent engineering roles in the Netherlands in 2020-21'.

Stockholm, Sweden

In Sweden, I secured an apartment in Södermalm, in central Stockholm. Accommodation, especially in the city centre, is expensive. The city exudes a Nordic charm and is the cultural, political, and economic capital of the country. I visited several tourist attractions in my free time including the Vasa museum and Gamla Stan (Old Town), which are two of the largest tourist attractions in Sweden.

Winters are usually extremely cold with many months of sub-zero temperatures. The very short days from late November to early January surprised me the most. In December, the sun rises at 8.30am and sets prior to 3pm, giving only six hours of daylight per day.

As a CQV engineer, my role in the biologics manufacturing facility was to provide support for the startup, commissioning, and qualification of a vial-filling line for a range of drug products. Typical equipment includes a vial washer, depyrogenation tunnel, vial filler/stopper, and vial capper.

Commissioning and qualification of manufacturing facilities, systems, and equipment is necessary to comply with regulatory requirements. Commissioning is the process of documenting that equipment, systems and facilities have been installed as expected and function correctly.

Rigorously tested and documented

Factory Acceptance Testing (FAT) is completed at the vendor facility, which is followed by Site Acceptance Testing (SAT) at the manufacturing facility.

Qualification ensures that equipment, systems, and facilities that have a direct impact on product quality are rigorously tested and documented. Qualification testing is completed through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). 

In March 2020, at the onset of the pandemic, Sweden pursued a very different approach to other countries in that a lockdown was not imposed on the population. Social events of more than 50 people were cancelled; however, bars and restaurants remained open, and no restrictions were imposed on travel within the country. In my office, colleagues were encouraged to work from home whenever possible, the wearing of face masks was made compulsory, and work desks were reorganised to comply with social distancing rules.

Project commissioning

Prior to the pandemic, most international contractors – especially those from Ireland and the UK – travelled home every second or third weekend to be with friends and family. Therefore, the cancellation of international flights had a huge impact; this forced many contractors to take the final available flights home and work remotely over the subsequent months (April-June).

As a result, on-site commissioning and qualification activities had to be re-prioritised and available resources reallocated when required. Inadvertently, and through necessity, a 'new-norm' way of working emerged whereby a collaboration of on-site resources, regular communication through virtual meetings, and remote support from colleagues, enabled our project commissioning and qualification activities to continue.

Amsterdam, the Netherlands

In August 2020, I secured a contract role as a senior CQV engineer at a biopharmaceutical manufacturing facility in the Netherlands. However, travelling across international borders amid an ongoing pandemic was a concern. As it turned out, international flights at the time were not restricted, and I flew to the Netherlands, without delay, in case the situation deteriorated.

I secured an apartment in Nijmegen city. It is the oldest city in the Netherlands and is located on the Waal river, close to the German border. It is famous for its annual ‘Four Day Marches’ event in July, which has unfortunately been cancelled since the start of the pandemic. I had to register at the Nijmegen municipality ‘gemeente’ to receive a citizen service number (BSN number), which is compulsory for all dealings with the Dutch government.

My role as a senior CQV engineer in the biologics manufacturing facility was to provide support for commissioning of two vial-filling lines. Devised specifically to manufacture a vaccine to counter the current coronavirus pandemic, this project was fast paced with an aggressive delivery timeline when compared to other similar sized projects completed prior to the pandemic. The existing manufacturing facility, systems, and equipment had to be adapted and repurposed for the manufacturing of a biological drug product and then qualified to meet current Good Manufacturing Practices (cGMP) and ensure regulatory compliance.

Good Documentation Practice

A sample of my daily tasks included assisting vendors with SAT executions, ensuring the vendor completed test steps per client specifications, and ensuring Good Documentation Practice (GDP) on the associated documentation. A risk-based strategy was employed in this project whereby vendor documentation was fully leveraged into qualification, therefore requiring a new level of quality control on these deliverables.

In Nijmegen, I witnessed a certain degree of normality in that bars and restaurants were not closed. In my office, face masks were compulsory and social distancing rules were implemented. In October, a partial lockdown came into effect followed by a hard lockdown in December – where all non-essential shops were closed. This proved an especially difficult period for expats, combining a lot of overtime on a busy project with no social events outside of work.

Quarantine rules and a negative COVID-19 test prior to international flights made it especially difficult for contractors returning home. In January 2021, the Dutch government introduced a nationwide curfew (9 pm-4.30am) to curb the spread of COVID-19, leading to many protests and riots in some cities.

In March, I undertook a new contract role as a senior CQV engineer at a clinical-stage biopharmaceutical company in Amsterdam. It was relatively easy to move from Nijmegen due to unrestricted travel within the country. Amsterdam is the capital and most populous city, and is colloquially known as the 'Venice of the North' because of its many canals. However, it is still noticeably quiet in the absence of international tourists.

I live in Amsterdam East (Amsterdam Oost), accommodation has been more readily available this year, and this is down to the exodus of many expats over the past 14 months or so. An excellent cycling infrastructure, along with a relatively flat topography, ensures that biking is one of the most popular methods of travelling within the city.

Living and working in Europe has been quite challenging during thepandemic, however, it has also been very rewarding in terms of experience gained in different roles and in different countries over a relatively short period of time.

The COVID-19 vaccine roll-out is still ongoing in the Netherlands as is the case in other countries around the world. Everybody living in the country is eligible for a vaccination. Once contractors have been vaccinated it should mean a 'more normal' existence for those working abroad and those seeking to work abroad in the not-too-distant future.

Author: Dermot Dineen (MIEI) is a senior Commissioning, Qualification and Validation (CQV) Engineer consultant for Hyde Engineering + Consulting Europe Limited and is currently based in Amsterdam (Netherlands). With 18 years’ validation experience in pharmaceuticals & biopharmaceuticals, he is a committee member of the Chemical & Process Engineering division of Engineers Ireland (2021-22). He holds a Bachelor of Engineering (BE) Degree in Food Process Engineering from University College Cork (1994-98). Email: dermot.dineen@gmail.com LinkedIn: https://www.linkedin.com/in/dermot-dineen