Validation and Qualification Engineer

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.

Additional info

The position is located at Bayer AS’ main offices at Lysaker in Oslo, Norway

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.

Application and Questions Regarding the Position:

The recruitment process is carried out in collaboration with the life sciences recruitment company Borka Consulting AS.

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.

**Questions:**For more information about this position before submitting your application, please contact: Cecilie Fraas Borka, phone +47 928 55 352 / email: cecilie@borka.no

How to apply: Please submit your application via the button "SØK HER"
**Application Deadline:**December 11th 2025.