Skills

Leadership Negotiation Change Management Training Analytics

Job Specifications

The Visual Inspection Specialist – Process Equipment is expected to :

- Act as Subject Matter Expert (SME) for visual inspection technologies within a major CAPEX aseptic

unit project, from concept through commissioning & PV. Ensure compliance with EU GMP Annex 1

(2022 revision), robust defect detection strategy, and integration of advanced digital tools (image

analytics, AI/ML) while maintaining data integrity and connectivity with MES/eBR systems.

1. Engineering & Design :

- Define and maintain URS for visual inspection systems (manual, semi-automatic, fully automated)

including camera-based and AI-assisted solutions.

- Lead design reviews ensuring ergonomic compliance, defect classification standards, and integration

with upstream/downstream processes.

- Ensure compliance with ISO 14644 for cleanroom zones where inspection occurs and Annex 1

requirements for container integrity and particle control.

- Collaborate on layout to minimize contamination risk and optimize inspection efficiency.

2. Commissioning, Qualification & Verification (CQV) :

- Develop and execute CQV plans for visual inspection equipment including IQ/OQ/PQ and

performance verification for defect detection capability.

- Validate automated vision systems per GAMP 5 (2nd ed.) and Annex 11 requirements; ensure image

data integrity and audit trail compliance.

- Coordinate FAT/SAT with vendors; manage deviations and CAPA through eQMS.

3. Regulatory & Quality:

- Ensure visual inspection processes comply with EU GMP Annex 1 (2022) and FDA Aseptic Processing

guidance.

- Maintain defect libraries and classification per industry standards; support trending and risk

assessments.

- Implement Data Integrity principles (ALCOA+) for image capture, storage, and review workflows.

4. Digitalization & Computerized Systems :

- Integrate visual inspection systems with MES/eBR for automated batch record updates.

- Deploy AI/ML algorithms for defect detection under Pharma 4.0 principles; validate models per GAMP 5 and CSA concepts.

- Ensure compliance with Annex 11 for computerized systems and maintain cybersecurity and access

controls.

5. Procurement & Vendor Management :

- Select and manmeetssuppliers for visual inspection equipment; ensure technical specifications and documentation meet GMP and CSV requirements.

- Benchmark emerging technologies (high-speed cameras, AI vision) and drive adoption of sustainable

solutions.

6. Leadership & Change Management :

- Promote a culture of quality and continuous improvement in visual inspection processes.

- Train operators and engineers on inspection techniques, defect recognition, and digital tools.

What are we looking for?

Requirements :

- Engineering or scientific degree (Automation, Optics,

Pharmaceutical Technology) or equivalent.

- 8+ years in pharmaceutical visual inspection systems and

aseptic operations.

- Experience with automated vision systems, defect classification,

and regulatory compliance.

- Knowledge of CSV and risk-based validation approaches (ASTM

E2500 considered an asset).

- Technical: manual/semi-automatic/automatic inspection systems, camera technology, AI/ML for

defect detection.

- Standards: EU GMP Annex 1 (2022), ISO 14644, GAMP 5 (2nd ed.), Annex 11, PIC/S PI 041-1.

- IT/OT: MES/eBR integration, image data management, cybersecurity.

- Soft skills: stakeholder engagement, vendor negotiation, training, and change management.

Regulatory References (knowledge required) :

- EU GMP Annex 1 – Manufacture of Sterile Medicinal Products (2022 revision).

- ISO 14644 – Cleanroom standards.

- ISPE GAMP 5 – Second Edition (2022).

- EU GMP Annex 11 – Computerised Systems.

- PIC/S PI 041-1 – Data Integrity.

- FDA Guidance – Aseptic Processing (2004).

About the Company

Pauwels Consulting is a Belgian consultancy firm with more than 1500 experts in engineering, life sciences and IT. We staff, manage and execute projects for leading organizations in Belgium, France, The Netherlands and beyond. Experts in Engineering, Life Sciences and IT Our Engineering team helps organizations in the (petro)chemical, civil engineering, industrial production, energy and transport businesses with the design, supervision, support and execution of long-term projects. We are particularly active in the fields o... Know more