IT Validation Lead
2 months ago
About the Role
We are seeking a highly skilled IT Validation Lead to join our team at Novo Nordisk A/S. As an IT Validation Lead, you will be responsible for defining and executing validation and qualification strategies for GxP and non-GxP Computerized Systems.
Key Responsibilities
- Drive and execute validation and qualification strategy, including making a Validation plan, Validation report, Design Review, Test strategy and execution etc.
- Conduct diverse assessments including Supplier, IT risk, IT requirements risk, and functional and data integrity assessments.
- Maintain system validation through regular reviews, deviation handling, and collaboration with System Managers and IT personnel to create and update system documentation and instructions as necessary.
- Ensure that systems are following relevant internal and external regulatory requirements, including finding solutions to compliance gaps identified in audits and inspections.
- Foster strong relationships with colleagues and stakeholders through effective communication, including workshops and risk assessments.
Requirements
- B.Sc. within Engineering, Chemistry, Pharmacy, IT or similar.
- Extensive and proven experience in one of the two: Computer System Validation (CSV) or manufacturing/production experience with recognized GMP certificate/qualification.
- Strong knowledge of IT GxP validation, preferably in a regulated industry such as pharma or healthcare. Relevant certifications such as GAMP5, CSQE, CVP, CQA, CQE, CRMA, CISA, or CRISC.
- Experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments.
- Excellent communication skills and the ability to effectively communicate with stakeholders, team members, and management.
About Us
Novo Nordisk A/S is a global healthcare company headquartered in Denmark. For 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases.
We are proud of our people too, and we employ more than 60,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change lives for people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued.
-
Validation Lead WareX
1 month ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full timeWe are on an exciting journey in rolling out SAP EWM, a Warehouse Management System (WMS), at various sites in Novo Nordisk. As a WareX Validation Lead, you will play a crucial role in ensuring the validation and compliance with regulatory requirements of our complex system landscape, and driving continuous improvement through innovative validation and...
-
Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full timeWe are a leading consultancy firm DIS/CREADIS - Dansk IngeniørService A/S, seeking a highly skilled QA and validation professional to join our team in Ballerup. Our company is experiencing significant growth and expansion in the life science industry.Compensation: The estimated salary for this position is approximately 550-650 EUR per hour or 80,000-110,000...
-
Purification Team Lead
2 months ago
Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full timeSeize the opportunity to lead a highly skilled team in the development of innovative antibody-based therapeutic products for the treatment of cancer and inflammatory/autoimmune diseases. As a critical member of our Downstream Process team, you will be responsible for the development and validation of downstream processes for monoclonal antibodies,...
-
Antibody Product Development Lead
2 days ago
Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full timeAbout the RoleWe are seeking an experienced Antibody Product Development Lead to join our team in Ballerup, Denmark. As a key member of our Purification team, you will lead the downstream process development of monoclonal antibodies and novel antibody formats.Key Responsibilities:Timely material supply supporting lead candidate selection in the discovery...
-
Test Management Lead
2 months ago
Ballerup, Ballerup Kommune, Denmark Epico-IT APS Full timeEmbark on a Mission to Transform Test Management at Epico-IT APSAre you prepared to spearhead a test management transformation at Epico-IT APS? Do you thrive in a culture that values Shift Left thinking and recognizes the pivotal role of test in agile development and DevOps? If so, this opportunity presents a thrilling challenge to take on the leading role...
-
Antibody Downstream Process Development Lead
4 weeks ago
Ballerup, Ballerup Kommune, Denmark Symphogen AS Full timeLead a Highly Skilled Team in Antibody DevelopmentSymphogen, a subsidiary of Servier and antibody center of excellence, is seeking an experienced professional to lead the downstream process development team.The successful candidate will have extensive hands-on experience in the pharmaceutical/biotech industry within downstream process development of antibody...
-
Antibody Development Lead in Oncology
1 week ago
Ballerup, Ballerup Kommune, Denmark Symphogen AS Full timeSeeking an experienced Antibody Development Lead to join our innovative team at Symphogen A/S, a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology.We offer a challenging and versatile job in an exciting environment with a meaningful mission: to advance superior monoclonal antibody therapeutics to...
-
Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full timeRole OverviewWe are seeking an experienced Lead Data Insights Analyst to join our Advanced Analytics team at GN Store Nord A/S in Ballerup, Denmark.About the RoleIn this exciting opportunity, you will play a key part in driving business growth through data-driven decision making. As a Lead Data Insights Analyst, your primary responsibility will be to design,...
-
Purification Team Lead
1 month ago
Ballerup, Ballerup Kommune, Denmark Unique Human Capital AS Full timeAntibody Therapeutic LeaderSymphogen A/S, a leading biotech company and the Antibody Center of Excellence, is seeking an experienced Purification Team Lead to join our innovative team.The ideal candidate will have extensive hands-on experience in downstream process development of antibody products and managerial expertise. They should be well-versed in novel...
-
Cloud Platform Product Lead
1 month ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeRole OverviewNovo Nordisk A/S is seeking a Cloud Platform Product Lead to drive the company's hybrid cloud containerization strategy. The ideal candidate will have a strong background in IT, preferably with experience in leading teams and managing complex products or projects.About the JobThe successful candidate will play a key role in defining and...
-
Senior Embedded Software Developer
1 month ago
Ballerup, Ballerup Kommune, Denmark Epico-IT APS Full timeWe are seeking a highly experienced Senior Embedded Software Developer to join our team at Epico-IT APS. As a key member of our software development team, you will play a vital role in creating cutting-edge Autopilot and steering control systems for marine vessels.With over 50 years of experience in developing intelligent steering systems, we have...
-
Lead Product Interaction Designer
1 day ago
Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full timeAbout the RoleAt GN Store Nord A/S, we are seeking a Lead Product Interaction Designer to join our Product UX team within the Interaction domain. In this role, you will play a pivotal part in designing intuitive, user-centric physical interfaces for our cutting-edge audio/video solutions.The ideal candidate will have solid experience working in a physical UX...
-
Strategic Business Development Associate
2 weeks ago
Ballerup, Ballerup Kommune, Denmark Queue-it Full timeAbout Queue-itQueue-it is a fast-growing tech company that helps the world's leading brands manage their busiest days. Our virtual waiting rooms prevent website crashes and bot abuse, creating a smoother online experience for billions of users.We're a diverse team of 40+ nationalities with offices in Denmark, the U.S., South Korea, and Australia. We believe...
-
Senior Business Development Specialist
1 month ago
Ballerup, Ballerup Kommune, Denmark Queue-it Full timeAbout UsQueue-it is a rapidly growing tech company that helps leading brands manage their busiest days. Our virtual waiting rooms prevent website crashes and bot abuse to create a seamless online experience for billions of users.We're a diverse team of experts from 40+ countries with offices in Denmark, the US, South Korea, and Australia.About the RoleAs a...
-
Ballerup, Ballerup Kommune, Denmark Genmab Full timeAbout the RoleGenmab is a leading biotechnology company committed to developing innovative antibody products and therapies that transform patient lives.We are seeking a skilled Senior LIMS System Administrator to join our QC Lab team. As a key member of our IT department, you will play a crucial role in ensuring the smooth operation of our Laboratory...
-
Key Account Business Growth Specialist
2 days ago
Ballerup, Ballerup Kommune, Denmark Queue-it Full timeAbout Queue-itWe are a tech scale-up that helps the world's biggest brands manage their busiest days. Our virtual waiting rooms prevent website crashes and bot abuse to create a smoother, fairer online experience for billions of users.Our team is diverse, with members from 40+ countries working together in Denmark, the U.S., South Korea, and Australia.About...
-
Ballerup, Ballerup Kommune, Denmark DISCREADIS - Dansk IngeniørService AS Full timeCompany OverviewWe are a leading consultancy firm, DIS/CREADIS - Dansk IngeniørService A/S, experiencing significant growth in the life science industry. We are seeking highly skilled professionals to join our team as Quality Assurance Specialists.Estimated SalaryThe estimated salary for this position is between 80,000 - 110,000 DKK per year, depending on...
-
Strategic Engineer
2 months ago
Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full timeAbout the PositionWe are seeking a skilled Utility Engineer to join our Clinical Supply Chain team at Novo Nordisk A/S.As a Utility Engineer, you will be responsible for managing and maintaining our facilities and equipment, including HVAC, BMS, and FMS systems.Your key responsibilities will include:Overseeing upgrades, rebuilds, and problem-solving...
-
Unlocking Growth as a Product Marketing Manager
1 month ago
Ballerup, Ballerup Kommune, Denmark Queue-it Full timeWe are seeking an accomplished Product Marketing Manager to drive the growth of our innovative technology solutions. With a strong focus on delivering exceptional customer experiences, this role will be at the forefront of positioning and promoting our products in the market.In this exciting position, you will leverage your expertise in product marketing to...
-
Business Development Associate
2 months ago
Ballerup, Ballerup Kommune, Denmark Queue-it Full timeAbout Queue-itWe are a tech scale-up helping the world's biggest brands manage their busiest days. Our virtual waiting rooms prevent website crashes and bot abuse, creating a smoother online experience for billions of users.About the RoleAs a Business Development Associate, you'll create quality connections with potential customers. You'll be the first point...