MES/CSV Validation Lead (GxP) - 6-Month Contract

Panda International; Portugal; Hybrid; EUR 83,000 - 124,000; Full time

Benefits offered by this job

Six‑month contract

Hybrid work arrangement (40% on-site)

Travel and subsistence expenses

Embedded project role

Job summary

Panda International seeks an experienced MES/CSV Lead for a six‑month contract in the Lisbon area, Portugal. The role is hybrid (approximately 60% remote, 40% on‑site) with an attractive hourly rate and travel/subsistence expenses included.

As an embedded contractor within the project team, you will validate Manufacturing Execution Systems in a GxP environment, report to the Project Manager and Quality Unit Owner, and ensure compliant, timely delivery across the validation lifecycle.

Qualifications

• Experience in GxP computerized systems validation with MES focus.
• Strong understanding of GMP requirements in pharmaceutical manufacturing.
• Hands-on technical experience in validation of hardware and software.
• Experience developing, reviewing and executing validation documentation.

Responsibilities

• Lead validation activities across the validation lifecycle using a risk-based approach.
• Conduct GxP risk assessments at system and Master Batch Record levels.
• Develop validation protocols including installation, functional testing, and performance verification.
• Create validation test scripts, oversee execution and review results.
• Manage non-conformances and prepare validation summary reports.
• Develop SOPs for system management and post-go-live activities.
• Validate interfaces between MES and SAP, shop-floor equipment, and quality systems.
• Support qualification of network and server infrastructure.
• Collaborate with stakeholders to ensure compliance and on-time delivery.

Skills

GxP validation

MES validation

Communication skills

English proficiency

Tools

IQ/OQ/PQ

Job description

Panda International seeks an experienced MES/CSV Lead for a six‑month contract in the Lisbon area, Portugal. The role is hybrid (approximately 60% remote, 40% on‑site) with an attractive hourly rate and travel/subsistence expenses included.

As an embedded contractor within the project team, you will validate Manufacturing Execution Systems in a GxP environment, report to the Project Manager and Quality Unit Owner, and ensure compliant, timely delivery across the validation lifecycle.