Downstream Validation Engineer – Scale-Up Biotech

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 650,000 - 850,000; Full time

Job summary

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) in Hillerød is seeking a Validation Engineer to join the downstream validation team. You will contribute to risk-based qualification of downstream equipment, participate in PPQs, and help ensure equipment readiness for production while supporting audits and inspections.

You will writeIQ/OQ/PQ protocols, review reports, and plan validation activities across all phases.

Qualifications

• Bachelor's or higher degree in Engineering or a relevant discipline with 3–5 years of industry experience.
• Knowledge of industry practices, practical experience, and a keen interest in hands‑on validation execution.
• Lean working methods and a risk-based approach to deliver efficient qualifications.
• Strong technical writing and communication skills to articulate complex information to stakeholders.
• Team player who thrives in collaboration and cross‑functional teams.
• Independent, adaptable, and dynamic in approach to work.

Responsibilities

• Write and review IQ, OQ and PQ protocols and write reports.
• Participate in PPQs and capex changes.
• Plan and prepare executions and validate cleaning processes.
• Plan, prepare, execute, and document all phases of validation.
• Write and update validation procedures and technical documents.
• Participate in audits and inspections.

Skills

Risk based qualification

Validation execution

Technical writing

Communication skills

Team player

Independent/adaptable

Education

Bachelor's or higher in Engineering

Job description

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) in Hillerød is seeking a Validation Engineer to join the downstream validation team. You will contribute to risk-based qualification of downstream equipment, participate in PPQs, and help ensure equipment readiness for production while supporting audits and inspections.

You will writeIQ/OQ/PQ protocols, review reports, and plan validation activities across all phases.