Senior System Engineer, Serialization

Posted 20 Days Ago
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Hillerød, Hovedstaden
Mid level
Biotech
The Role
The Senior System Engineer manages GxP IT systems, ensuring their operation, maintenance, and documentation while supporting users and driving digitalization initiatives.
Summary Generated by Built In

We are looking for an experienced System Engineer to help with the driving, operation, and maintenance of the GxP and non-GxP IT systems in the Finished Goods Manufacturing area. You will be a single point of contact and escalation for the system(s) you will be managing. The position resides in our Global IT organization, where we support and drive the data supported innovation and digitalization across our six sites. The position itself is situated at our site in Hillerød.

Are you passionate about joining us in the journey of further scaling and developing our data capabilities in one of the most agile and creative teams in a large developing organization? Are you excited about making a difference and driving digitalization? Then apply here.

About the Department and Team

You will join the global IT organization as part of the Data Platform and Enabling systems team. Data is becoming increasingly more valuable and relevant not only to us in IT but also to the business and to our partners. We work together in the team to provide data to our stakeholders and support the business in achieving their goals.

The work environment is international and informal. We keep a high pace and focus on a vital work life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Our working model is a hybrid between working from home and working from our offices in Hillerød or our satellite office in Copenhagen.

Job Responsibilities

As System Engineer you will be a single point of contact and escalation for the system(s) you will be managing. You oversee the day-to-day administration and maintenance of Tracelink and Uhlmann, ensuring data accuracy and system performance. You will collaborate with cross-functional teams to understand business requirements and translate them into effective system solutions, and you will work closely with other IT peers. Impact will primarily be end-user satisfaction, but also overall system availability and functionality.

Furthermore, you will need to ensure that the most appropriate level of service are supplied to meet future business needs. You will be responsible for 2nd level support for the system(s) and making sure that guidelines, how-to's and other relevant documentation is available for 1st level support. It is also expected from you to drive smaller deployment or upgrade projects as well as participate in a larger IT and compliance projects.

Among other things, you will:

  • Ensure that the most appropriate level of service is supplied to meet future business needs.
  • Implement best practices for administration in accordance with the global standards.
  • Assess the current state & identify opportunities for improvement and best practice recommendations.
  • As the system engineer you will follow procedures and work instructions for high-risk tasks and you are expected to resolve issues and understand further path for system-related challenges, although you may need help from peers/management and other teams for complete resolution.
  • Be responsible for 2nd level support for the system(s) and make sure that guidelines, how-to's and other relevant documentation are available for 1st level support. You will act as the primary point of contact for troubleshooting and resolving technical issues related to the system.
  • Monitor data integrity and security, implementing best practices and ensuring compliance with data protection regulations.
  • Stay informed about the system updates, trends, and emerging technologies to recommend innovative solutions and you will implement best practices for administration in accordance with the global standards.

Professional Qualifications

  • Min 3 years of operation and maintenance of IT systems, preferably within the pharmaceutical industry.
  • Experience in admin functions related to data sources and extracts.
  • Experience in data integrity and security.
  • Experience in managing a system in a structured and organized manner.
  • Experience with production IT Projects and administration of IT systems.
  • Quality mindset, structured, with strong analytical skills and a high sense of responsibility.
  • A strong analytical and methodical approach to troubleshooting/investigation and capable of presenting issues and viable solutions.
  • Able to communicate & work with fellow team members and other functional team members to coordinate and deliver goals.
  • Desired: Experience with data management, building global processes.
  • Desired: Understanding and knowledge of GAMP.
  • Desired. Engineering background

Personal Qualifications

As a person you approach tasks and colleagues with openness and great energy. You possess an analytical mindset and understand the importance of involving stakeholders in your daily work. You are self-starting and have a flexible, dynamic approach to work. Lastly, if you see yourself as a high performing team player who is ambitious on behalf of yourself and the company, then you might be just the candidate, we are looking for!

Your application:
If this sounds interesting to you, then we urge you to upload your resume and application as soon as possible, as we will be having interviews on an on-going basis until the right candidate has been found.

For any questions about the position, you can reach out to the Global Lead for the Data Platform and Enabling Technologies: Camilla Hansen, [email protected]

About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines, and advanced therapies. The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.
FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.
We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

What we offer
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Top Skills

Tracelink
Uhlmann
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The Company
HQ: Billingham
4,554 Employees
On-site Workplace
Year Founded: 2011

What We Do

For over 30 years, FUJIFILM Diosynth Biotechnology’s mission has been advancing tomorrow’s medicine. As a CDMO, we work in partnership with the most innovative biopharma and biotech companies across the world who are reimagining healthcare’s potential. We help to accelerate their progress, expand their capabilities, streamline their processes, and strengthen their innovation. So when our customers’ potential cures, vaccines, biologics, and accomplishments make strides – or even become new realities for patients – we know our work, our manufacturing expertise, and our partnership helped make it happen.

FDB isn’t simply a workplace. It’s a place of passion – a place of what we call Genki. A place where diverse perspectives and people come to life. Where opportunity for growth has no end. Where passion is followed, discovered, and nurtured. Where the energy is undeniable, enthusiasm is pervasive, and drive is infectious. All of our global locations burst with curiosity, inspiration, and extraordinary purpose.

So as we continue to grow our teams, our global locations, and our capabilities, Genki will always be our cultural tie. That’s why we’re always looking for passionate, mission-driven people who want to commit their life’s work to enabling better outcomes for patients and their families.

For a full listing of jobs that will propel, inspire, and fulfill you, please visit: fujifilmdiosynth.com/careers/

We created this space on LinkedIn to give people a window into work and culture at FDB. We’re highlighting employees’ passion, current openings, and why it’s never been a more exciting time to join FDB.

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