MES/CSV Lead (Freelance)

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

We are seeking an experienced MES/CSV Lead for a six-month contract with a pharmaceutical manufacturing organisation in the Lisbon area, Portugal. This hybrid role involves approximately 40% on-site work (60% remote) and offers a competitive hourly rate, plus travel and subsistence expenses.

Working as an embedded contractor within the internal project team, you will report to the Project Manager and Quality Unit Owner, leading the validation of Manufacturing Execution Systems (MES) within a GxP-regulated environment.

Key Responsibilities

• Lead and document activities throughout the computerised systems validation lifecycle, applying a risk-based approach.
• Conduct GxP risk assessments at both system level and Master Batch Record level.
• Develop validation protocols covering installation, functional testing, and performance and acceptance verification.
• Create validation test scripts, oversee test execution, and review test results.
• Manage non-conformances and prepare validation summary reports.
• Develop system management and operational SOPs to support post-go-live activities.
• Validate interfaces between MES and other systems, including shop-floor equipment, SAP, and quality systems.
• Perform validation and qualification activities covering plant hardware, software installation, master data, and system configuration.
• Support the qualification of network and server infrastructure associated with validated systems.
• Collaborate with project stakeholders, suppliers, and cross-functional teams to ensure compliance and successful project delivery.

Required Qualifications and Experience

• More than seven years of experience in GxP computerised systems validation, with a strong focus on MES validation.
• Background in pharmaceutical manufacturing and a solid understanding of GMP requirements.
• Hands‑on technical expertise in computerised systems validation, including hardware and software qualification.
• Practical experience with IQ/OQ/PQ activities and validation documentation.
• Strong knowledge of GAMP 5 principles, data integrity requirements, and risk-based validation approaches.
• Understanding of electronic records and electronic signatures regulations, including FDA 21 CFR Part 11 and EU GMP Annex 11.
• Experience developing, reviewing, and executing validation documentation within a regulated environment.
• Strong verbal and written communication skills in English. Portuguese language skills are an advantage.

Preferred Qualifications

• Experience with SAP, LIMS, or other GxP-regulated systems.
• Familiarity with oral solid dosage manufacturing and packaging processes.
• Experience applying risk-based validation strategies, including Agile approaches or Computer Software Assurance (CSA).
• Strong stakeholder management and collaboration skills, with a pragmatic and solutions‑oriented mindset.

What We Offer

• A six-month contract within a pharmaceutical manufacturing environment.
• A hybrid working arrangement, with approximately 40% on‑site presence.
• An opportunity to contribute to a significant MES validation project.
• An embedded project role involving close collaboration with internal stakeholders and validation specialists.
• A competitive hourly rate, plus travel and subsistence expenses.

This role is suited to a hands-on MES/CSV specialist who can take ownership of validation activities, bring strong technical expertise, and ensure compliance with applicable GxP requirements throughout the system validation lifecycle.