Asset Engineer (CQV) - Ghent, Belgium (Fully Onsite)

Overview

We are seeking an experienced Asset Engineer (Commissioning, Qualification & Validation) to join a leading pharmaceutical manufacturing facility in Ghent, Belgium. This position is responsible for ensuring manufacturing equipment, utilities, and systems remain qualified, compliant, and in a validated state throughout their lifecycle.

The successful candidate will act as a technical owner for assigned assets and lead qualification activities supporting GMP manufacturing operations, capital projects, remediation initiatives, and continuous improvement programs.

Location: Ghent, Belgium
Working Model: Fully Onsite
Industry: Pharmaceutical / Biotech / Cell & Gene Therapy

Key Responsibilities

Commissioning, Qualification & Validation (CQV)

• Lead equipment and utility qualification activities from planning through execution and approval.
• Prepare, review, and approve qualification documentation including:
  • URS (User Requirements Specifications)
  • DQ (Design Qualification)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • Qualification Plans & Reports
  • Validation Master Plans (VMP)
  • Risk Assessments
• Ensure qualification activities are completed in accordance with GMP requirements, internal procedures, and project timelines.
• Support commissioning and qualification activities for new equipment, system upgrades, facility modifications, and expansion projects.
• Review executed qualification testing and ensure deficiencies are appropriately resolved.

Technical Ownership

• Act as Technical Owner for assigned manufacturing equipment, utilities, and facility systems.
• Provide technical expertise and troubleshooting support to Manufacturing, Engineering, QA, and other site functions.
• Assess equipment changes, modifications, investigations, and remediation activities for qualification impact.
• Support lifecycle management activities to maintain equipment in a validated state.

Quality & Compliance

• Manage and support:
  • Change Controls
  • Deviations
  • Investigations
  • CAPAs
  • Remediation Activities
• Perform qualification impact assessments for quality events and system changes.
• Create and maintain records within TrackWise and other quality systems.
• Partner with QA to ensure qualification packages meet regulatory and internal compliance requirements.
• Support internal audits and regulatory inspections.

Project Support

• Participate in project planning and cross-functional meetings.
• Coordinate qualification activities with stakeholders across:
  • Engineering
  • Manufacturing
  • Facilities
  • Validation
  • Quality Assurance
• Ensure required resources, documentation, testing materials, and schedules are in place.
• Provide regular project updates and escalate risks where necessary.

Continuous Improvement

• Support improvements to qualification and validation processes.
• Identify compliance gaps and opportunities for process enhancement.
• Contribute to qualification strategy development and site-wide CQV improvements.
• Support onboarding and training of junior team members when required.

Required Experience

• Bachelor's Degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or related discipline.
• Experience within GMP-regulated pharmaceutical, biotechnology, biologics, sterile manufacturing, or cell & gene therapy environments.
• Proven experience performing equipment and utility qualification activities.
• Strong working knowledge of:
  • IQ/OQ/PQ
  • GMP regulations
  • Validation lifecycle principles
  • Risk-based qualification approaches
• Experience managing change controls, deviations, CAPAs, and investigations.
• Experience authoring and reviewing qualification documentation.
• Experience working with electronic quality systems such as TrackWise.

Preferred Experience

• Cell Therapy or CAR-T manufacturing experience.
• Facility, cleanroom, HVAC, and utility qualification experience.
• Experience supporting inspections and audits.
• Knowledge of Annex 15, ISPE, and GAMP guidance.
• Technical ownership responsibilities within manufacturing environments.

Key Skills

• Commissioning & Qualification (C&Q)
• CQV
• Equipment Qualification
• Validation Engineering
• GMP Compliance
• IQ / OQ / PQ
• Change Control
• Deviations & CAPAs
• Risk Assessment
• Technical Ownership
• TrackWise
• Pharmaceutical Manufacturing
• Utility Qualification
• Facility Qualification
• Root Cause Analysis
• Continuous Improvement

Please note: This role is 100% onsite in Ghent, Belgium, and candidates must be able to work on-site regularly. No remote or hybrid working arrangement is available.