Senior MSAT Validation & Lifecycle Lead

Bristol Myers Squibb; Leiden; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Bristol Myers Squibb Netherlands in Leiden is seeking a Senior Specialist, MSAT Validation & LCM to provide process validation and lifecycle management support at the Leiden Cell Therapy Facility.

You will lead validation activities including APS/APV, PPQ, data analysis, and risk mitigation, interfacing with process engineers and cross-functional teams.

The role emphasizes cGMP compliance, inspections readiness, and contributions to continuous improvements within a global network.

Competenze

• Bachelor’s degree in science/engineering/biochemistry or related discipline; advanced degree preferred.
• Minimum 5 years’ experience in biopharmaceutical operations.
• Knowledge of cGMPs and multinational regulations.

Mansioni

• Supports validation activities for new products or processes at the Leiden facility.
• Oversees CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis and prepares protocols, reports, and summaries.
• Designs and executes test plans and conducts risk mitigation investigations.
• Interfaces with process engineers and serves as process validation SME.
• Supports lifecycle management changes and site implementations.
• Ensures safe, compliant cGMP operations and supports regulatory inspections.

Conoscenze

cGMP knowledge

Validation expertise

Facility design experience

Formazione

Bachelor’s degree in science/engineering/biochemistry

Advanced degree preferred

Descrizione del lavoro

Bristol Myers Squibb Netherlands in Leiden is seeking a Senior Specialist, MSAT Validation & LCM to provide process validation and lifecycle management support at the Leiden Cell Therapy Facility.

You will lead validation activities including APS/APV, PPQ, data analysis, and risk mitigation, interfacing with process engineers and cross-functional teams.

The role emphasizes cGMP compliance, inspections readiness, and contributions to continuous improvements within a global network.