Qualification validation Engineer

Akkodis; Eigenbrakel; Presencial; EUR 111.000 - 166.000; Jornada completa

Descripción de la vacante

Akkodis is seeking a contingent Qualification & Validation specialist to strengthen our pharmaceutical manufacturing site in Belgium. You will support periodic qualification reviews, execute qualification and validation activities, and lead packaging equipment qualification and serialization projects.

The role requires hands-on experience with CSV, URS, risk assessments, IQ/OQ/PQ, and the ability to work independently.

Formación

• Minimum 5 years of experience in Qualification & Validation.
• Proven hands-on experience in qualification and validation of packaging equipment and packaging lines.
• Experience with serialization projects, including implementation and qualification of serialization modules.
• Mandatory experience in Computerized System Validation (CSV).
• Experience writing and executing qualification documentation (URS, Risk Assessments, IQ/OQ/PQ).
• Ability to perform qualification and validation activities independently.
• Strong problem-solving skills.
• Autonomous and proactive mindset.
• Positive attitude and solution-oriented approach.
• Fluency in French.
• Ability to read and write technical documentation in English.
• Availability and commitment for the full duration of the assignment.

Responsabilidades

• Support the periodic review of qualification status and execution of qualification and validation activities.
• Lead and support packaging equipment qualification projects and serialization module qualification.
• Perform CSV activities and documentation (IQ/OQ/PQ).
• Collaborate with stakeholders across qualification/validation processes.
• Identify issues and propose appropriate solutions; ensure timely execution and follow-up.

Conocimientos

Problem-solving

Autonomous

Proactive

French fluent

Descripción del empleo

We are looking for a contingent worker to strengthen its Qualification & Validation activities with a strong focus on packaging equipment qualification, serialization projects and CSV activities.

The consultant will support ongoing qualification activities related to packaging lines and serialization modules, while also contributing to broader qualification projects across the site.

The first priority will remain the support of Periodic Qualification Review activities, followed by qualification projects involving packaging, manufacturing equipment, utilities and cold rooms.

Department

The position is part of a pharmaceutical manufacturing environment focused on Qualification & Validation activities related to production, packaging and computerized systems.

Key Responsibilities

• Support the periodic review of qualification status.
• Execute qualification and validation activities.
• Lead and support packaging equipment qualification projects.
• Support implementation and qualification of serialization modules.
• Perform Computerized System Validation (CSV) activities.
• Support qualification activities related to manufacturing equipment, utilities, cold rooms and booths/logettes.
• Identify issues and propose appropriate solutions.
• Ensure timely execution and follow-up of assigned activities.
• Collaborate with stakeholders involved in qualification and validation processes.

Typical Day

Activities may include:

• Reviewing qualification documentation and equipment status.
• Preparing and executing qualification and validation protocols (IQ/OQ/PQ).
• Participating in serialization implementation and qualification projects.
• Performing CSV documentation and validation activities.
• Investigating deviations and technical issues.
• Supporting project activities and maintaining qualification documentation.
• Coordinating with operational and project teams.
• The role combines both documentation and hands‑on qualification/validation activities.

Candidate Profile

Must-Have

• Minimum 5 years of experience in Qualification & Validation.
• Proven hands‑on experience in qualification and validation of packaging equipment and packaging lines.
• Experience with serialization projects, including implementation and qualification of serialization modules.
• Mandatory experience in Computerized System Validation (CSV).
• Experience writing and executing qualification documentation (URS, Risk Assessments, IQ/OQ/PQ).
• Ability to perform qualification and validation activities independently.
• Strong problem-solving skills.
• Autonomous and proactive mindset.
• Positive attitude and solution-oriented approach.
• Fluency in French.
• Ability to read and write technical documentation in English.
• Availability and commitment for the full duration of the assignment.

Nice-to-Have

• Experience with Wipotec serialization technology.
• Experience qualifying utilities, cold rooms and manufacturing equipment.
• Additional experience within a regulated pharmaceutical environment.

Languages

• French: Mandatory
• English: Reading and writing skills required