Senior CTU Validation Engineer & Strategy SME

FujiFilm; Hillerød; On-site; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Competitive compensation package

Job summary

FUJIFILM Biotechnologies seeks an experienced Validation Engineer/SME to lead CTU qualification programs for refrigerators, freezers, cold rooms and related equipment at our Hillerød site. You will set validation strategy, own lifecycle activities, and coordinate inspections with regulators.

The role requires deep regulatory knowledge, hands‑on CQV expertise, and the ability to drive risk assessments, CAPAs and changes while ensuring GMP compliance and inspection readiness.

Qualifications

• Bachelor's or higher in a relevant engineering/biotech domain.
• 8+ years' CTU validation experience in pharma/biotech.
• Expertise with IQ/OQ, CQV, CAPAs and change controls.

Responsibilities

• Serve as Validation SME for CTUs and lead qualification strategies.
• Drive inspection readiness, audits, and regulatory responses.
• Own validation lifecycle, including IQ/OQ, RQ and continued verification.
• Lead risk assessments, deviations investigations and CAPA processes.

Skills

Regulatory compliance expertise

Validation lifecycle management

IQ/OQ/PQ familiarity

Risk assessment & GMP knowledge

Audits & inspections support

Education

Bachelor's, Master's or equivalent in Engineering/Biotech/Pharma

Job description

FUJIFILM Biotechnologies seeks an experienced Validation Engineer/SME to lead CTU qualification programs for refrigerators, freezers, cold rooms and related equipment at our Hillerød site. You will set validation strategy, own lifecycle activities, and coordinate inspections with regulators.

The role requires deep regulatory knowledge, hands‑on CQV expertise, and the ability to drive risk assessments, CAPAs and changes while ensuring GMP compliance and inspection readiness.