Asset CQV Engineer
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.
Additional Requirements
- Candidates must have full working rights in Belgium or the EU.
- Sponsorship and visa support are not available for this position.
- Candidates requiring current or future work permit sponsorship cannot be considered.
- Ability to work full-time onsite in Ghent, Belgium is essential.
FAQs
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