Downstream Validation Engineer — Scale Biotech Production

FujiFilm; Hillerød; On-site; DKK 520,000 - 760,000; Full time

Benefits offered by this job

Fitness access

Canteen

Job summary

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) in Hillerød is expanding its Validation team. We seek a driven Validation Engineer to qualify downstream processes and support PPQ and capex changes.

You will write IQ/OQ/PQ protocols, review reports, and document validation activities while ensuring readiness for audits and inspections. The role requires a Bachelor's or higher in Engineering, 3-5 years in validation, and strong technical writing plus cross-functional collaboration with

Qualifications

• Bachelor's or higher degree in Engineering or a relevant discipline.
• 3-5 years of industry experience in validation.
• Experience with IQ/OQ/PQ protocols and reports.
• Ability to write and review validation documentation.

Responsibilities

• Participate in PPQs and capex changes.
• Write and review IQ, OQ, PQ protocols and reports.
• Plan and execute cleaning validation and validation procedures.
• Support audits and inspections.

Skills

Validation execution

Risk-based approach

Technical writing

Strong communication

Team player

Hands-on

Independent/adaptable

Education

Bachelor's or higher in Engineering or relevant discipline

Job description

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) in Hillerød is expanding its Validation team. We seek a driven Validation Engineer to qualify downstream processes and support PPQ and capex changes.

You will write IQ/OQ/PQ protocols, review reports, and document validation activities while ensuring readiness for audits and inspections. The role requires a Bachelor's or higher in Engineering, 3-5 years in validation, and strong technical writing plus cross-functional collaboration with