Senior CTU Validation Engineer | GMP Compliance & CQV

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive compensation package

Global opportunities

Fitness access

Attractive canteen

Job summary

FUJIFILM Biotechnologies Denmark is seeking an experienced Validation Engineer / Validation SME to drive CTU validation programs, including refrigerators, freezers, cold rooms, and incubators, ensuring compliance with global regulatory requirements.

You will lead qualification activities, risk-based validation strategies, audits, and inspections readiness, working with cross-functional teams across GMP operations at our Hillerød site.

Qualifications

• Bachelor's, Master's, or equivalent degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related.
• 8+ years of CTU and validation experience in pharma/biotech/life sciences.
• Experience qualifying CTUs and production equipment; IQ/OQ and CQV knowledge.
• Understanding of GMP regulations (EU/ICH) and inspection readiness.

Responsibilities

• Serve as Validation SME for CTUs and own validation strategy and lifecycle.
• Lead qualification activities: IQ, OQ, RQ, and continued lifecycle verification.
• Drive risk-based validation approaches and Quality Risk Assessments.
• Support audits, regulator inspections, and remediation of observations.
• Collaborate with cross-functional teams to ensure compliance and timely delivery.

Skills

CTU validation

Validation SME

Regulatory knowledge

Audit readiness

Stakeholder management

Autonomy

Quality risk management

Education

Bachelor's/Master's in Engineering/Biotech/Pharma

Job description

FUJIFILM Biotechnologies Denmark is seeking an experienced Validation Engineer / Validation SME to drive CTU validation programs, including refrigerators, freezers, cold rooms, and incubators, ensuring compliance with global regulatory requirements.

You will lead qualification activities, risk-based validation strategies, audits, and inspections readiness, working with cross-functional teams across GMP operations at our Hillerød site.