Validation Engineer - Pharma - English/French [F/M/X]

Amaris Group SA; Sint-Katelijne-Waver; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading pharmaceutical company in Belgium is seeking a Validation Project Coordinator. Responsibilities include leading validation activities for major GMP projects and ensuring compliance with all regulatory requirements. Candidates should have at least 5 years of experience in validation within a GMP environment and be fluent in both French and English. The role offers an opportunity to work within a diverse and inclusive team.

Qualifications

• Minimum 5 years of experience in validation.
• Expertise in IQ/OQ/PQ validation and strong knowledge of GMP.
• Fluent in French and English.

Responsabilités

• Coordinate validation activities for major GMP projects.
• Develop and implement validation strategies and plans.
• Draft, review, and approve validation documentation.
• Ensure compliance with regulatory requirements.

Connaissances

Validation within a GMP environment

IQ/OQ/PQ validation

Communication skills

Organizational skills

Injectable product validation

Project management

Description du poste

Validation Engineer - Pharma - English/French [F/M/X]

Job Offer: Validation Project Coordinator

Mission Description: As a Validation Project Coordinator, you will be responsible for leading and coordinating validation activities for major GMP projects related to Drug Substance and Drug Product manufacturing. You will ensure that validation strategies are state-of-the-art, from the planning phase through to the Validation Summary Report. Your responsibilities will include drafting, reviewing, and approving validation documents such as Risk Assessments, IQ/OQ/PQ protocols, and reports, as well as coordinating the execution of validation protocols.

Key Responsibilities:

• Coordinate validation activities for major GMP projects in Drug Substance and Drug Product.
• Develop and implement validation strategies and plans.
• Draft, review, and approve validation documentation (Risk Assessments, IQ/OQ/PQ protocols, reports).
• Oversee and coordinate the execution of validation protocols.
• Ensure compliance with regulatory requirements and internal standards.
• Collaborate cross-functionally within a matrix organization.

Profile Requirements:

• Minimum 5 years of experience in validation within a GMP environment.
• Expertise in IQ/OQ/PQ validation and strong knowledge of GMP.
• Experience in project management and working within a matrix organization.
• Excellent communication, organizational, and influencing skills.
• Experience with injectable product validation.
• Fluent in French and English.

Commitment to Diversity: We are proud to be an equal opportunity employer. We are committed to promoting diversity within the workforce and creating an inclusive working environment. Therefore, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.