MSAT Validation & Lifecycle Lead

Biopharma Careers; Leiden; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb Netherlands 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, support PPQ, APS/APV, and risk assessments, and collaborate with cross-functional teams across site and network.

The role requires 5+ years in biopharmaceutical operations, knowledge of cGMPs, and strong data analysis and communication skills; a Bachelor’s degree is required,

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline.
• Minimum 5 years’ experience in biopharmaceutical operations.
• Advanced degree preferred.

Responsibilities

• Supports validation activities for new products or processes related to the Leiden Cell Therapy Facility.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis and prepares protocols/reports supporting validation studies and lifecycle management.
• Design and execute test plans and other risk mitigation exercises as part of investigations.
• Interface with process engineers and serve as process validation SME.
• Supports site implementation of Lifecycle Management changes and validation-related activities.
• Leads/Owns site Change Controls and participates in risk assessments.
• Supports regulatory inspections and maintains cGMP readiness.

Skills

cGMP knowledge

Biopharma regs

Facility design

Process validation

Audit experience

Communication Skills

Education

Bachelor's in science/engineering/biochemistry

Advanced degree preferred

Job description

Bristol Myers Squibb Netherlands 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, support PPQ, APS/APV, and risk assessments, and collaborate with cross-functional teams across site and network.

The role requires 5+ years in biopharmaceutical operations, knowledge of cGMPs, and strong data analysis and communication skills; a Bachelor’s degree is required,