Validation and Qualification Engineer - Lab Infrastructure Responsible
Bayer
Validation and Qualification Engineer - Lab Infrastructure Responsible
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Oncology is one of the strategic therapeutic areas for Bayer Pharma and radiopharmaceuticals are an important part of this strategy with several projects in phase I and preclinical pipeline. To support the growing pipeline and increased activities in the Targeted Radionuclide Therapy field, we are looking for an experienced Validation Engineer to join our Radiopharmaceutical CMC & Technology team based in Oslo.
Position Overview:
We are seeking a dedicated and skilled Validation Engineer to take on the responsibility of our lab infrastructure. This newly created position will play a crucial role in ensuring that our laboratory equipment meets the highest standards of quality and compliance.
Key Responsibilities:
- Lab Management: Oversee and perform the planning, execution, and documentation of the procurement and qualification of GMP equipment/analytical systems, including computer system validation.
- Calibration and Requalification: Ensure that the calibration and requalification of GMP equipment/analytical systems are performed consistently and accurately.
- Qualification Plans: Establish and ensure compliance with overarching qualification plans, including conducting periodic reviews of analytical systems.
- SOP Management: Maintain overall responsibility for Standard Operating Procedures (SOPs) related to analytical systems and laboratory infrastructure, ensuring alignment with applicable regulations and global Bayer SOPs.
- Service and Maintenance: Oversee service and maintenance activities and perform qualification of service providers.
- Change Management: Manage deviations and changes related to lab infrastructure and analytical systems.
- Audit and inspections: Prepare for, participate in and follow up audits and inspections.
- Subject Matter Expertise: Act as a competence resource for qualification of equipment and analytical systems within the Analytical development and quality control department, focusing on continuous improvement of processes and workflows.
Qualifications:
- A bachelor's degree, master's degree, or engineering degree in a relevant field (e.g. Pharmacy, Chemistry, Biotechnology, Biochemistry, Physics) is required. Alternatively, a technician with extensive experience in the field of qualification/validation of GMP equipment and analytical systems will be considered.
- Experience with GMP and HSE within a laboratory environment.
- Experience working with radioactive or hazardous materials is an advantage, though not required, as comprehensive training will be provided.
- Strong IT skills, including data management capabilities.
- A genuine interest in technology with solid technical skills.
- Excellent collaboration skills and a strong team spirit.
- Service-oriented mindset.
- Strong oral and written communication skills in English and one of the Scandinavian languages.
- A minimum of five years of relevant professional experience
What We Offer:
- A dynamic work environment with opportunities for professional growth.
- Comprehensive training and support.
- The chance to be part of a dedicated team focused on quality and compliance in laboratory settings.
- Inclusive work environment with competent and engaged colleagues.
Application Process:
If you are passionate about ensuring quality and compliance in laboratory environments and meet the qualifications outlined above, we invite you to apply. Please submit your resume and a cover letter detailing your relevant experience and interest in the position.
We will review the applications on continuous basis. We reserve the rights to close the advert earlier.
Deadline for Applications: December 11th 2025.
Contact details
The recruitment process is carried out in collaboration with the consulting company Borka Consulting AS. If you would like to find out more about this position before submitting your application, please do not hesitate to contact Cecilie Fraas Borka, phone +47 928 55 352 / cecilie@borka.n
Functional area: CMC Radiopharmaceuticals
Seniority level: Professional
#LI-NOR
- Team
- Pharma
- Locations
- Bayer Norway
- Employment type
- Full-time
- Last application date
- 11 December, 2025
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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity, and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
About Bayer Nordic
At Bayer we always start by listening – because our customers are at the heart of everything we do. The needs of our customers and the challenges facing society inspire us to develop ideas that improve people’s lives. As part of the Bayer team, each of us needs to thoroughly understand and support our customers in order to deliver products and solutions that matter – now and in the future
Bayer Nordic is our regional organization for Northern Europe. You find us in Finland, Denmark, Norway, Sweden, Iceland and the Baltic countries, i.e. Estonia, Latvia and Lithuania. We are more than 1400 people who are passionate to make a difference.
In the Nordic region we have two global R&D and production sites, in Finland and Norway. The Turku-based production facility is one of the Group's global pharmaceutical production facilities, where medicines are manufactured for more than 130 countries. Over the last years Bayer has increased its investments, research activities and partnerships in the Nordics, and we are proud of being one of the most significant Life Science companies in the region.
Why Bayer? Because we’re a pioneer in the fields of human and plant health. Because we invent the solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.