Senior CTU Validation Engineer — GMP & Inspections

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

Benefits offered by this job

Fitness facilities

Canteen

Career growth opportunities

Job summary

FUJIFILM Biotechnologies Denmark (FLBD) is seeking an experienced Validation Engineer / Validation SME to drive CTU validation activities across refrigerators, freezers, cold rooms, and related equipment. The role requires deep regulatory knowledge and strategic direction for qualification and validation programs.

You will act as validation SME, lead CQV activities, support inspections, and ensure compliance with global regulatory requirements while enabling operations and expansion projects at

Qualifications

• 8+ years of CTU validation experience in pharma/biotech.
• Experience qualifying CTUs and production equipment.
• Strong IQ/OQ and CQV experience.
• Knowledge of EU GMP Annex 1/15, ICH and FDA regs.
• Experience supporting regulatory inspections and observations.

Responsibilities

• Serve as Validation SME for one type of CTU (Refrigerators).
• Own validation program for CTUs and lifecycle.
• Lead validation activities including IQ, OQ, PQ, and lifecycle verification.
• Support customer audits and regulatory inspections.
• Drive inspection readiness and remediate audit findings.
• Develop validation strategies and risk-based approaches.
• Maintain validated state of CTUs throughout their lifecycle.
• Collaborate with cross-functional teams and stakeholders.

Skills

Validation SME

Regulatory knowledge

Stakeholder management

Autonomy

Education

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

Tools

IQ/OQ

Requalification

CQV

Quality Risk Management

Change Control

Deviations

Investigations

CAPAs

Job description

FUJIFILM Biotechnologies Denmark (FLBD) is seeking an experienced Validation Engineer / Validation SME to drive CTU validation activities across refrigerators, freezers, cold rooms, and related equipment. The role requires deep regulatory knowledge and strategic direction for qualification and validation programs.

You will act as validation SME, lead CQV activities, support inspections, and ensure compliance with global regulatory requirements while enabling operations and expansion projects at