Process Validation Engineer (Continued Process Verification)

Location: Ghent, Belgium
Contract Type: Freelance / Contract
Duration: Until March 2027
Start Date: ASAP
Working Pattern: Full-Time (40 Hours per Week)
Working Model: On-Site
Industry: Pharmaceutical / Biotechnology Manufacturing

Overview

We are supporting a leading pharmaceutical manufacturer in the search for a Process Validation Engineer to join their Manufacturing Science & Technology (MSAT) team.

This position will focus on Continued Process Verification (CPV), process performance monitoring, statistical analysis, and lifecycle process validation activities within a GMP-regulated manufacturing environment. The successful candidate will work closely with cross-functional stakeholders to ensure manufacturing processes remain compliant, robust, and capable throughout the product lifecycle.

This is an excellent opportunity for an experienced validation professional seeking exposure to advanced manufacturing operations, data-driven process improvement, and complex GMP production environments.

Key Responsibilities

Continued Process Verification (CPV)

• Support the generation and maintenance of CPV reports.
• Analyse manufacturing process performance data and identify trends.
• Monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Identify and investigate process drift, variability, and out-of-trend results.
• Support ongoing process validation and lifecycle management activities.
• Contribute to maintaining the validated state of manufacturing processes.

Data Analysis & Process Monitoring

• Collect, organise, and analyse manufacturing and analytical data.
• Perform statistical analysis and process trending activities.
• Utilise statistical tools to evaluate manufacturing performance.
• Generate technical reports and performance summaries.
• Support process monitoring strategies and performance reviews.
• Translate manufacturing data into actionable recommendations.

Quality & Compliance

• Support deviation investigations and root cause analysis activities.
• Assist with risk assessments and CAPA implementation.
• Ensure all activities are performed in accordance with GMP requirements.
• Collaborate with Quality teams to maintain compliance standards.
• Support inspection readiness and documentation activities.

Continuous Improvement

• Identify opportunities for process optimisation and operational efficiency.
• Support implementation of process improvements.
• Participate in performance review meetings and technical discussions.
• Contribute to manufacturing excellence initiatives.
• Support development of monitoring and control strategies.

Cross-Functional Collaboration

• Partner with Manufacturing, Quality, Validation, Engineering, and Technical Operations teams.
• Support project activities across multiple functions.
• Present technical findings and recommendations to stakeholders.
• Work within multidisciplinary teams to achieve project objectives.

Required Experience

• Bachelor's Degree or higher in Engineering, Biotechnology, Pharmacy, Biomedical Sciences, Life Sciences, or a related discipline.
• Minimum 5 years of experience within pharmaceutical or biotechnology manufacturing environments.
• Hands-on experience with Continued Process Verification (CPV).
• Strong understanding of Process Validation lifecycle principles.
• Experience analysing manufacturing process performance.
• Knowledge of GMP and cGMP requirements.
• Experience supporting manufacturing operations within regulated environments.
• Strong technical writing and reporting capabilities.
• Excellent analytical and problem-solving skills.

Preferred Experience

• Experience within biologics, sterile manufacturing, advanced therapies, or cell therapy environments.
• Experience within Manufacturing Science & Technology (MSAT).
• Exposure to technology transfer activities.
• Experience supporting deviation investigations and CAPA implementation.
• Familiarity with statistical process monitoring methodologies.
• Experience presenting technical information to cross-functional stakeholders.

Technical Skills

• Continued Process Verification (CPV)
• Process Validation
• GMP / cGMP Compliance
• Statistical Analysis
• Process Monitoring
• Data Trending
• CPP & CQA Analysis
• Root Cause Analysis
• Risk Assessment
• Deviation Management
• CAPA
• Technical Reporting
• Manufacturing Data Analysis
• Lifecycle Process Validation
• Quality Systems

Key Competencies

• Strong analytical mindset.
• Excellent attention to detail.
• Effective stakeholder management skills.
• Ability to work independently and proactively.
• Strong organisational and prioritisation skills.
• Ability to manage multiple activities within a fast-paced environment.
• Strong written and verbal communication skills.
• Collaborative approach to problem-solving and continuous improvement.

What's on Offer

• Long-term contract opportunity through March 2027.
• Competitive hourly rate.
• Opportunity to work within a highly regulated manufacturing environment.
• Exposure to advanced process validation and lifecycle management activities.
• Collaborative and technically challenging project environment.
• Significant cross-functional engagement across Manufacturing, Quality, and Technical Operations teams.