CSV & DI Team Lead – Pharma Validation & Risk

ALTEN; Geel; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Company car

Meal vouchers

Recovery days

Insurances

Résumé du poste

ALTEN Belgium is seeking a CSV & DI Team Leader to co-lead CSV and Data Integrity efforts on site, aligning with industry best practices. You will mentor the Local Process Owner, oversee project delivery with regulatory compliance, and drive change management across the organization.

The role requires on-site presence (min 80%), expertise in pharma CSV/DI, and experience with systems like DeltaV, PI, and PCS7. A permanent contract and competitive package are offered.

Qualifications

• Deep understanding and hands-on experience with CSV and data integrity in a pharma manufacturing environment.
• Experience in API environments with knowledge of DeltaV, PI, PCS7 and alarm management.
• Strong knowledge of FDA and EMA CSV/data integrity requirements, with risk-based validation experience.
• Excellent project management, organizational and coordination skills.
• Strong communication and interpersonal abilities; capable of leading teams in complex settings.
• Coaching, human change management and training skills; able to influence across levels.

Responsabilités

• Provide direction on CSV & DI best practices and risk-based approaches.
• Oversee projects and resources to deliver on plan with quality and compliance.
• Partner with QA lead to ensure alignment of outputs and deliverables.
• Drive organizational adoption of best practices and processes.
• Mentor the Local Process Owner to uplift knowledge to industry standards.

Connaissances

CSV & Data Integrity expertise

Project management

Leadership experience

Interpersonal communication

Coaching & training

Outils

DeltaV

PI

PCS7

Description du poste

ALTEN Belgium is seeking a CSV & DI Team Leader to co-lead CSV and Data Integrity efforts on site, aligning with industry best practices. You will mentor the Local Process Owner, oversee project delivery with regulatory compliance, and drive change management across the organization.

The role requires on-site presence (min 80%), expertise in pharma CSV/DI, and experience with systems like DeltaV, PI, and PCS7. A permanent contract and competitive package are offered.