Validation Engineer

6 days ago

Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full time

Are you looking for new and exciting challenges in validation?

Fujifilm Diosynth Biotechnologies (FDB) in Hillerød is expanding, and to ensure support to the continuous growing number of equipment and systems, we are looking for a Validation Engineer, sharing our passion, drive, and energy – to join our team.

We are looking for Validation Engineers who will complement the team’s current skills and with experience in one or more of the below listed areas:

  • Qualification of process equipment in Cell Culture or Purification (Up-/Down-stream)
  • Qualification of Cleaning in place (CIP) or steaming in place (SIP)
  • Cleaning validation

In the first half year, you are expected to support the Performance Qualification for our expansion project. After that you will move on to the Validation department and join the Validation team for Up- or Down-stream. Responsible for Validation of equipment changes and Cleaning Validation in relation to Tech Transfer of new products.

About the department and the team
The Validation department is part of a global organization. The Validation department is responsible for maintaining the validated state of equipment within the large-scale manufacturing drug substance facility. This includes qualification of new equipment, chamber validation, cleaning validation, participation in projects/changes and Tech Transfers of new products. The department supports the existing production facility but is also a huge part of the large expansion projects.

Main responsibilities

  • Preparing, performing, and documenting commissioning, IQ, OQ and PQ activities
  • Participating and executing change controls
  • Planning and participation in projects with validation impact
  • Planning, executing, and documenting all phases of cleaning validation
  • Preparation of validation planning/ reporting documents for product campaigns
  • Writing and updating validation procedures and documents
  • Participation in audits and inspections, answering regulatory requests

Qualifications
You hold a Bachelor or higher degree in Engineering or other relevant discipline and have at least 3 years of relevant industry experience. You have demonstrated knowledge of industry practices, practical experience, and interest in hands-on validation execution.
You are conscious of lean ways of working and able to apply a risk-based approach to deliver efficient qualification. For this role you need to have strong technical writing and excellent communication skills, as you will have to articulate complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, Maintenance, etc.
You are a team player who enjoys working with colleagues and in cross-functional teams. As a person you bring a friendly, can-do behavior, professionalism, and a good sense of humor. You are independent and have a flexible, dynamic approach to work.

Your application
For more information about the open position, please contact Martin Therkelsen Validation Manager at +45 25663099 or Hanne Toft, Associate Director Validation at +45 23712992. Please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis.

Working at FUJIFILM Diosynth Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.

#J-18808-Ljbffr

  • Validation Engineer

    6 days ago

    Hillerød, Denmark Novo Nordisk AS Full time

    Do you want to play a key role in introducing new production equipment enabling Novo Nordisk to deliver medical pen systems to our patients around the world? Are you experienced in validation documentation, GMP and maybe even injection moulding? Then you might be the talented validation engineer we are looking for to ensure that new moulds are brought...

  • Project Validation Engineer

    4 weeks ago

    Hillerød, Denmark Novo Nordisk AS Full time

    Are you interested in playing a pivotal role in a new capacity expansion project that will shape the future of API (Active Pharmaceutical Ingredient) production facilities? Do you have a passion for establishing structured standards and a proven track record in qualification and validation within the pharmaceutical industry? If so, this is your opportunity...

  • Validation Engineer

    7 days ago

    Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full time

    We are seeking an experienced Validation Engineer to join our team at Novo Nordisk A/S. As a key member of our Global Contract Manufacturing Devices department, you will play a critical role in introducing new production equipment and ensuring compliance with GMP regulations.About the RoleThe successful candidate will be responsible for reviewing validation...

  • Senior Assembly Engineer

    6 days ago

    Hillerød, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Hillerød, Denmark Jobkategori Manufacturing Ansøg nu Are you passionate about process optimization and implementing new technology? Do you want to be part of a journey to transform Aseptic Manufacturing Finished Product (AM FP) Site Hillerød into the “Factory of the Future”? If so, join us as a Senior Assembly Engineer -...

  • Validation and Qualification Expert

    2 weeks ago

    Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time

    Job DescriptionWe are seeking a highly skilled Validation and Qualification Expert to join our team at FUJIFILM Diosynth Biotechnologies in Hillerød, Denmark.About the RoleIn this role, you will be responsible for preparing, performing, and documenting commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance...

  • Global Lead for IT Compliance

    1 week ago

    Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full time

    Global Lead for IT Compliance & Validation Apply locations Hillerod time type Full time posted on Posted 3 Days Ago time left to apply End Date: January 19, 2025 (18 days left to apply) job requisition id JR3984 As the Global Lead for IT Compliance & Validation, you will help set the overall Computerized System Validation (CSV) strategy and delivery support...

  • Global Lead for IT Compliance

    2 weeks ago

    Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full time

    Global Lead for IT Compliance & Validation Apply locations Hillerod time type Full time posted on Posted 3 Days Ago time left to apply End Date: January 19, 2025 (18 days left to apply) job requisition id JR3984 As the Global Lead for IT Compliance & Validation, you will help set the overall Computerized System Validation (CSV) strategy and delivery support...

  • Digital QA Expert for Automated Systems and Validation

    7 days ago

    Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Digital QA Expert to join our team in Hillerød, Denmark.Job DescriptionThe successful candidate will be responsible for ensuring the quality and compliance of all processes in FPMSAT, including product development and life cycle management, design control, testing, manufacturing development, and manufacturing...

  • Experienced QA Professional for digital and automated systems validation

    3 weeks ago

    Hillerød, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Experienced QA Professional for digital and automated systems validation Category: Quality Location: Hillerød, Capital Region of Denmark, DK Are you motivated by regulatory requirements and automated processes to produce, test and launch important medical devices and combination products? Do you...

  • Automation Engineer

    1 week ago

    Hillerød Kommune, Denmark Hamlyn Williams Full time

    Get AI-powered advice on this job and more exclusive features. Specialist Consultant | Automation and Validation Engineering | EU Life Science Contract Recruitment Automation Engineering - Pharma The DeltaV Infrastructure Specialist bridges pharmaceutical manufacturing and automation engineering, ensuring reliable and compliant DeltaV systems critical for...

  • Senior Assembly Engineer

    2 weeks ago

    Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full time

    Job Opportunity:We are seeking a highly skilled Senior Assembly Engineer to join our team at Novo Nordisk A/S in Hillerød, Denmark. As a key member of our Assembly Back Office, you will play a crucial role in ensuring the validated state of our production equipment.About the Role:In this position, you will be responsible for driving various projects related...

  • API Production Engineer

    4 weeks ago

    Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking an experienced API Production Engineer to join our team at Novo Nordisk A/S, where you will play a pivotal role in ensuring the quality and compliance of our API production facility. In this position, you will be responsible for leading cross-functional teams to implement standardized quality-related tools, monitor quality during...

  • Biopharmaceutical Process Engineer Position in Denmark

    2 months ago

    Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time

    About the RoleWe are seeking a highly skilled Biopharmaceutical Process Engineer to join our team in Hillerød, Denmark. In this role, you will be responsible for ensuring the downstream equipment readiness for the manufacture of future clinical and commercial products.Key ResponsibilitiesAct as an Engineering Subject Matter Expert (SME) providing support to...

  • Pharma Engineer for Denmark Projects

    2 weeks ago

    Hillerød, Hillerød Kommune, Denmark aptio group Denmark ApS Full time

    Aptio Group ApS, a rapidly growing engineering consultancy in Denmark, is seeking skilled engineers to work on exciting pharma projects in the Copenhagen area. As a successful candidate, you will become an integral part of our project organization and contribute to delivering exceptional results.With a focus on Good Manufacturing Practice (GMP) related work,...

  • Senior Automation Engineer for Pharmaceutical Processes

    1 week ago

    Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full time

    FUJIFILM Diosynth Biotechnologies is a leading biologics contract development and manufacturing organization (CDMO) with operations in Denmark, UK, USA, and other locations. We are currently seeking a highly skilled Senior Automation Engineer to join our Plant Engineering & Support team.About the Role:This position involves working on the automation...

  • CQV Engineer

    4 months ago

    Hillerød, Denmark aptio group Denmark ApS Full time

    Driven CQV Engineer for Fast Growing Consultancy Are you a driven Commissioning/Qualification/Validation Engineer interested in participating in pharma facility engineering projects in the Copenhagen Metropolitan Area in Denmark? If so, Aptio Group wants to meet you! In Aptio Group, we are looking to staff several exciting pharma engineering projects in...

  • Utility Automation Engineer within Plant Engineering

    6 days ago

    Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full time

    We are looking for a new colleague to join our Utility Automation team in Plant Engineering & Support in Hillerød. Are you interested in the overall automation strategy, structure, compliance, validation, projects, and maintenance of SCADA systems in a GMP environment? Then you might be just the candidate we are looking for! About the position Our new...

  • Senior HVAC Engineer

    2 weeks ago

    Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time

    Are you a skilled engineer looking for a new challenge in the rapidly growing field of Pharmaceutical Manufacturing?Fujifilm Diosynth Biotechnologies, a leading industry player, is seeking an experienced Senior HVAC Engineer to join their Plant Engineering team in Hillerød, Denmark.About the JobThis exciting role involves providing engineering support for...

  • Automation Solutions Engineer

    2 months ago

    Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full time

    Unlock the Power of Automation at Novo NordiskWe are seeking a skilled Automation Solutions Engineer to join our team in Hillerød, Denmark.About the RoleThis is an exciting opportunity to work on scalable and sustainable automation technologies that enable shopfloor value. As an Automation Solutions Engineer at Novo Nordisk, you will support process control...

  • Responsible Engineer for HVAC in Plant Engineering

    2 months ago

    Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full time

    Responsible Engineer for HVAC in Plant Engineering Are you ready to take on new challenges while having fun at the same time? Do you want to be part of the largest CDMO in Europe? FUJIFILM Diosynth Biotechnologies is growing our locations, our capabilities, and our teams, and we are therefore looking for passionate, mission-driven people like you who want...