CTU Validation Engineer & SME Lead

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking an experienced Validation Engineer / Validation SME to drive CTU qualification and validation programs including IQ/OQ, risk assessments, and lifecycle strategies. The role supports regulatory readiness, inspections, and cross‑functional collaboration across the Hillerød site.

The candidate will lead validation activities for CTUs (refrigerators, freezers, incubators) and partner with QA and operations to ensure compliance with EU GMP and global standards.

Qualifications

• Bachelor's, Master's or equivalent degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
• 8+ years of CTU and validation experience in pharma/biotech/life sciences.
• Experience qualifying and maintaining CTUs and production equipment.
• Knowledge of IQ/OQ, Requalification, QRM, Change Control, Deviations, Investigations, CAPAs, and CQV.
• Familiarity with EU GMP Annex 1/15, ICH Q8/9/10, ISPE, ISO 14644, ASTM E2500, GAMP, and FDA requirements.

Responsibilities

• Serve as Validation SME for CTUs (Refrigerators or CTU types).
• Own validation strategy and lifecycle for CTUs across their lifecycle.
• Lead IQ/OQ, CQV, and risk assessments.
• Respond to regulatory observations and inspections.
• Drive inspection readiness and remediation of audit findings.
• Collaborate with cross-functional teams on validation initiatives.

Skills

Validation

Quality Risk Mgmt

Change Control

Deviations

Investigations

CAPAs

CQV

GMP Annex 1

Education

Bachelor's/Master's in Engineering or Life Sciences

Job description

FUJIFILM Biotechnologies is seeking an experienced Validation Engineer / Validation SME to drive CTU qualification and validation programs including IQ/OQ, risk assessments, and lifecycle strategies. The role supports regulatory readiness, inspections, and cross‑functional collaboration across the Hillerød site.

The candidate will lead validation activities for CTUs (refrigerators, freezers, incubators) and partner with QA and operations to ensure compliance with EU GMP and global standards.