Senior MSAT Validation & Lifecycle Lead

Bristol Myers Squibb; Leiden; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Senior Specialist, MSAT Validation & LCM to support validation activities at the Leiden Cell Therapy Facility. You will lead process validation, lifecycle management, and cross-functional collaborations with process engineers and quality teams.

The role emphasizes hands-on validation execution, data analysis, and risk mitigation, ensuring cGMP compliance and readiness for regulatory inspections. Hybrid work model and growth opportunities are offered.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline; advanced degree preferred.
• Minimum 5 years' experience in biopharmaceutical operations.
• Knowledge of cGMP's and multinational biopharmaceutical/cell therapy regulations.
• Experience in facility/clean room design, process, equipment, automation, and validation.
• Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs).
• Excellent verbal/written communication skills and ability to influence at all levels.

Responsibilities

• Supports validation activities for new products or processes at the Leiden CTF.
• Responsible for CTF Process Validation including APS/APV and PPQ.
• Performs data analysis and prepares protocols/reports for validation studies.
• Designs and executes test plans and risk mitigation investigations.
• Interfaces with process engineers and acts as process validation SME.
• Supports Lifecycle Management changes and site implementation.
• Leads site Change Controls.
• Participates in risk assessments and authors qualification/validation documents.
• Supports investigations and global change controls.
• Ensures compliant cGMP operations and readiness for inspections.
• Supports continuous improvements to reduce risks, costs, lead times.
• Serves as MSAT representative on cross-functional teams.
• Maintains collaborative relationships across site and network.
• Foster strong inter-team relationships to achieve goals.
• Support MSAT management in productivity and financial goals.
• Participate in routine plant operating meetings.

Skills

cGMP compliance

Facility design

Process validation

Audits experience

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry

Advanced degree preferred

Job description

Bristol Myers Squibb Netherlands is seeking a Senior Specialist, MSAT Validation & LCM to support validation activities at the Leiden Cell Therapy Facility. You will lead process validation, lifecycle management, and cross-functional collaborations with process engineers and quality teams.

The role emphasizes hands-on validation execution, data analysis, and risk mitigation, ensuring cGMP compliance and readiness for regulatory inspections. Hybrid work model and growth opportunities are offered.