Month: August 2023

Welcoming Marlous van der Hooft: Leading Scitech’s Expansion into Germany

Posted on by maxxadmin

Having nearly two decades of expertise in establishing, managing and leading radiopharmaceutical manufacturing processes, facilities, and sites, Marlous is well-respected within the field. Marlous’s exceptional track record includes the successful launch of 13 production sites across Europe, both for principal and contract manufacturing. Her dedication and leadership have left an indelible mark on the industry, setting the stage for operational excellence and continuous improvement.

With a background in pharmaceutical microbiology, Marlous’s proficiency spans a wide spectrum – from lean manufacturing and process enhancement to quality control, QC method development, validation and compliance, supply chain management, regulatory strategy and medicines licensing.

Marlous’s appointment as Scitech GmbH Managing Director and General Manager underscores our commitment to driving innovation and expanding our horizons. As an integral part of the Scitech family, Scitech GmbH will provide quality and regulatory consulting, qualification and validation services, design and engineering and other consultancy support within the traditional pharmaceutical environment, primarily in German-speaking Europe. Additionally, Scitech GmbH will also operate as a global centre of excellence in radiopharmaceuticals, supplementing and drawing on the extensive proficiency of subject matter experts from across the Scitech group. 

Marlous’s extensive knowledge and visionary leadership are poised to elevate Scitech’s presence in Germany and beyond. 

Marlous said: “I am delighted to lead Scitech’s expansion into Germany, a vibrant hub of scientific innovation and collaboration. This presents an extraordinary opportunity for Scitech to further solidify its presence on the global stage, contributing to groundbreaking advancements in radiopharmaceutical manufacturing. Together, we will unlock new possibilities, forge impactful partnerships, and continue to drive excellence in delivering cutting-edge solutions to benefit patients and the healthcare community.”

We warmly welcome Marlous van der Hooft to the Scitech family and eagerly anticipate the incredible contributions she will make as we venture into new frontiers.

Spotlight on Daniel Woods, Computer System Validation Lead

Posted on by Simon

In the latest spotlight interview, we speak to Daniel Woods about his career path to becoming a Computer System Validation Lead working with highly technical pharmaceutical, biotechnology, and life science companies.

Daniel admits that back in his student days, he didn’t envisage a career in computer system validation (CSV) – in fact he hadn’t even heard of CSV. What he did enjoy, which is what ultimately set him on his path to a successful career with Scitech, is an interest in computer systems. “When I was at college I had dreams of becoming a music producer, which while it is obviously a vastly different career, also has a technical element. I have always had an interest in computer systems and that is what led me to where I am today.”

An unexpected career path

Daniel began working for a company specialising in small-scale, complex formulation sterile packing as a Machine Operator. “Originally, I intended this to just be a temporary summer job but an opportunity arose for an Operations Compliance role. Here, I took on computerised system projects, managing the implementation of these projects on site and also took on continuous improvement opportunities.”

Daniel went on to gain several years’ experience working within the pharmaceutical industry and building up contacts within the sector which led him to successfully secure a role within Scitech. Daniel said: “Many CSV engineers have a Computer Science or IT degree or a degree in Microbiology or Biotechnology. However, that isn’t the only route into a Computer System Validation role. On-the-job experience can also provide a gateway into roles such as this and experience is always going to be invaluable, particularly when the job – outside of the industry – is broadly unknown and when working in highly regulated sectors.”

The role of a CSV Engineer

Daniel explains that it is the role of Computer System Validation engineers to provide lifecycle support to the deployment and maintenance of all GxP computerised systems. “We are responsible for planning, writing, implementing and reviewing various life-cycle documents, including, but not limited to, validation plans, user requirement specifications, vendor design documents, code reviews, FAT/SAT protocols, qualification protocols, Data Integrity assessments, risk assessments, etc., to ensure the computer system(s) meet GxP regulatory requirements and function efficiently and effectively. This applies to new equipment or facilities and includes changes to existing processes, products, systems, and facilities. Essentially it is the responsibility of the CSV engineer to ensure that the GxP computerised systems are fit for purpose and operate as intended.”

Daniel has since gone on to achieve two internal promotions and is now a Computer System Validation Lead at Scitech. He now manages a team of Computer System Validation Engineers. “At Scitech we have a really positive culture that nurtures professional and career development. I have been able to draw on the experience of other senior team members, and there is always the opportunity to attend conferences and events to ensure that we are fully abreast of industry trends and regulatory updates. In turn, I make sure that I am equally as supportive to my team by running development sessions to further expand their knowledge and capabilities.”

The future of CSV: a rising demand

Daniel believes that the need for Computer System Validation Specialists is only going to grow in the future as equipment, systems and processes become increasingly reliant on computerised systems to drive them. Regulators also expect organisations to rely on computerised systems more to support their processes. This is further supported by the recent GAMP 5 Second Edition guidance which includes great initiatives like critical thinking and modern testing methods that’s really exciting to see and provides some great opportunities for organisations and CSV professionals alike. “The beauty of working in this role within a highly technical sector is that the different technology keeps you challenged-; which keeps it interesting. It’s also interesting seeing how different organisations have different yet similar challenges in the implementation of computerised systems. If you have an interest in computer systems then this would definitely make an interesting career choice.”

● Find out about the career opportunities at Scitech.

Empowering Women at Scitech: Overcoming workplace challenges with confidence

Posted on by Simon

In our latest initiative to support professional growth of our female colleagues, our Women at Scitech group recently held an empowering session aimed at helping women break through workplace barriers. Colleagues from across Scitech’s various offices took part in an enriching interactive session led by the experienced Executive Coach and Trainer, Anne Messer, Managing Director of Bespoke Training Services.

The session revolved around addressing common challenges faced by women in the workplace, with a specific focus on imposter syndrome, lack of confidence, and assertiveness. These obstacles have been known to hinder individuals from reaching their full potential and delivering their best work.

As a coach and an industry expert, with specific experience of designing and delivering leadership programmes for women, Anne Messer was the perfect facilitator for creating awareness to support personal and professional growth.

During the interactive session, Anne delved into the concept of imposter syndrome, which plagues even the most accomplished individuals. Attendees were encouraged to share their experiences and challenges openly, fostering a supportive environment where everyone felt heard and understood.

The session also covered strategies to build self-confidence and establish a distinctive ‘personal brand.’ By encouraging participants to recognise their unique strengths and talents, Anne encouraged everyone to leverage these qualities to their advantage.

A significant focus of the training meeting was on assertiveness – a skill vital for women to assert themselves confidently in the workplace particularly in male dominated sectors. Anne provided practical tips and techniques to empower attendees, equipping them to navigate challenging situations with grace and effectiveness.

Anne Messer, Executive Coach and Trainer said: “Success and fulfilment in the workplace come from embracing your uniqueness, believing in your capabilities, and fearlessly pursuing your goals, even in the face of imposter syndrome. Remember, you are your greatest asset, and when you conquer self-doubt, you unleash your true potential, making the possibilities truly boundless.”

Participants left the training meeting armed with tools to conquer the obstacles that may have been holding them back in their professional journeys.

“We believe that fostering an inclusive and supportive environment is crucial for the success of every individual in our organisation,” said Emma Dawas, HR Manager at Scitech. “Through this session, we aimed to empower our female colleagues, providing them with the skills and confidence to excel in their roles.”

The Women at Scitech group plans to continue organising such initiatives regularly, striving to create an equitable workplace where talent and dedication are nurtured, regardless of gender. By investing in the growth and empowerment of its members, Scitech reaffirms its commitment to creating a diverse and progressive work environment.