Experienced QA Professional for Validation and Automation/IT
2 days ago
Category:
Quality
xx
Are you ready to play a key role in building a new groundbreaking biotech Active Pharmaceutical Ingredients (API) production facility? As a QA Professional at Novo Nordisk, you’ll lead quality assurance efforts during the design and construction phases, ensuring compliance and setting quality standards. Can you handle complex quality issues and drive best-in-class solutions? Join us in shaping the future of pharmaceutical innovation, apply now
The position
In this role, you will be part of a highly skilled QA team allocated to perform quality assurance activities during design and construction of the new API production facility in Hillerød. The QA team will support the project throughout the project phases of the facility, hereby securing quality oversight and setting the direction for implementation of cGMP. As a QA Professional, you will be part of a fantastic QA team and you will be reporting to an Associate QA Manager.
Your main responsibilities will be to:
- Setting the quality direction for the project within automation and IT
- Deliver best in class quality oversight and approval for automation and IT validation activities
- Handle larger and complex quality issues and act as sparring partner regarding quality matters for your stakeholders
- Communicate and explain the internal and external requirements such as EU GMP and GAMP5 for the project team members and relevant project stakeholders to achieve high level compliance
- Promote and support a strong quality culture in close collaboration with our stakeholders in the project team
We are seeking the right candidate to join our team and will place them in a job level that aligns with their experience and skills. We encourage professionals at all levels—whether junior or senior to apply.
Qualifications
To succeed in this role, you have:
- An academic degree within automation, IT, science or another relevant field
- Some years’ experience within validation/qualification of IT, automation and/or equipment
- Gained said experience from the pharmaceutical or medical devices industry
- Knowledge of GMP requirements for Active Pharmaceutical Ingredients production
- Full English proficiency
It would be seen as an advantage if you have experience with DCS and MES systems, IT infrastructure and software.
On a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, when the waves get high. You demonstrate great communication skills and are able to clearly and precisely communicate complex matters to stakeholders, thriving a multicultural environment working across organizational borders and management levels.
Building structures comes naturally to you and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner.
Are you not quite fulfilling the above qualifications but still think you’re a good match for the position for other reasons? Don’t hesitate to apply and tell us why.
About the department
API Expansions QA 25L is a department with 15 motivated colleagues with experience ranging from lesser experienced to expert, all based in Hillerød. Our focus is to ensure compliance, timely approval and the foundation for flawless operation of our new facilities while making our department the best place to work. We enjoy having a good laugh together and emphasizes psychological safety as well as continuous individual improvement. We are a multicultural team and our daily spoken and written language is English.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
If you require further information, please contact Associate Manager Emma Grund Secher on phone +45 34440721
Deadline
31 January 2025
You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
xx
-
Hillerød, Denmark Novo Nordisk AS Full timeSelect 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...
-
IT Validation Expert for Pharmaceuticals
2 days ago
Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking an experienced QA Professional to lead quality assurance efforts during the design and construction phases of our new API production facility. The ideal candidate will have a strong background in automation, IT, and quality oversight, with experience working in the pharmaceutical industry.
-
Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full timeWe are currently expanding our automated and digitalized facilities across all production phases, both locally and globally. Our team at FPMSAT QA sets the compliance direction for operations in transportation, intralogistics, laboratories, testing equipment, testing methods, digital solutions, robotics, and automation.Key Responsibilities:Establish and...
-
Validation Engineer
3 days ago
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeAre 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...
-
Validation Engineer
3 days ago
Hillerød, Denmark Novo Nordisk AS Full timeDo 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...
-
QP and Head of QA Drug Substance
3 days ago
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeAre you motivated to lead and inspire four dedicated QA Drug Substance teams within a rapidly growing CDMO? Fujifilm Diosynth Biotechnologies in Hillerød is looking for a proactive and passionate individual to take on the role of Head of QA Drug Substance. This position offers a unique opportunity to embody our core values of trust, customer satisfaction,...
-
Senior Validation Engineer
12 hours ago
Hillerød, Denmark Novo Nordisk AS Full timeCategory: Manufacturing Are you motivated by managing complex manufacturing equipment and advancing our technological capabilities? If so, this is a fantastic opportunity to make a meaningful impact and leave your mark at the Factory of the Future. Apply today! The Position We have an open position in the Back Office team, where you'll join a highly...
-
Project Validation Engineer
3 days ago
Hillerød, Denmark Novo Nordisk AS Full timeAre you ready to play a crucial role in a groundbreaking capacity expansion project for Active Pharmaceutical Ingredient (API) production facilities? Do you have a passion for setting high standards and a solid background in qualification and validation within the pharmaceutical industry? Join our team as a Project Validation Engineer (PVE) and help shape...
-
Global Lead for IT Compliance
3 days ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeGlobal 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...
-
Senior Assembly Engineer
3 days ago
Hillerød, Denmark Novo Nordisk AS Full timeJobbeskrivelse 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 -...
-
Automation Engineer
3 days ago
Hillerød Kommune, Denmark Hamlyn Williams Full timeGet 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...
-
Hillerød, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Category: Digital & IT Location: Hillerød, Capital Region of Denmark, DK Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Are you driven by automation and digitalization of the Novo Nordisk manufacturing value chain? Look no further! We are building a talent...
-
Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full timeFUJIFILM Diosynth Biotechnologies, a leading biologics contract development and manufacturing organization, is seeking a skilled System Automation Specialist to join its team in Hillerød, Denmark.As a System Automation Specialist, you will play a key role in the Utility Automation team, providing technical support for plant utilities and manufacturing...
-
Hillerød, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Hillerød, Denmark Jobkategori Quality Ansøg nu Do you want to use your leadership skills to motivate, develop and set a clear direction for a team of highly skilled employees? Are you eager to take on new challenges and impact the future of our Device Component manufacturing QA (DCM QA) organization? Do you want to play a vital...
-
Quality Oversight Professional
1 day ago
Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full timeResponsibilities- Develop and implement quality oversight strategies for automation and IT validation activities- Collaborate with cross-functional teams to ensure compliance with regulatory requirements- Identify and resolve complex quality issues- Communicate effectively with stakeholders to achieve high-level compliance- Promote a culture of quality...
-
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeWe 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...
-
Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled Advanced Quality Assurance Professional to join our team in Hillerød. The successful candidate will be responsible for ensuring the quality strategy is implemented and adhered to, both internally and externally.The PositionHandle cases related to production on automated inspection lines and Environmental...
-
Analytical Equipment Specialist
3 days ago
Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full timeJob OverviewWe are seeking an experienced Senior QC Equipment Chemist to join our team at Novo Nordisk A/S. This is a unique opportunity for a skilled professional to contribute to the development of our digitalized laboratory.About the PositionThe Senior Chemist will be part of one of our three Chemical Control teams, responsible for ensuring the quality of...
-
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeWe are looking for a new colleague to join our Utility Automation team in Plant Engineering & Support in Hillerød. Are you interested in utility automation, trouble shooting, maintenance and minor project work? Then you might be just the candidate we are looking for! About the position Our new Utility Automation Engineer will provide support to our...
-
Hillerød, Hillerød Kommune, Denmark Novo Nordisk AS Full timeWe are seeking a seasoned manager to lead our Decoration Equipment team, driving collaboration and innovation in the pharmaceutical industry.About the RoleLead a team of 12 experienced employees responsible for sourcing and commissioning equipment across the global network of suppliers and Contract Manufacturers.Foster a culture of high team commitment and...