Senior MSAT Validation & Lifecycle Specialist

Bristol-Myers Squibb Co; Leiden; Hybrid; EUR 90,000 - 110,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a Senior Specialist, MSAT Validation & LCM to provide validation and lifecycle support at the Leiden Cell Therapy Facility. You will participate in facility, process and aseptic validation activities, work on tech transfers, and support lifecycle changes with cross-functional teams.

Role requires strong cGMP knowledge, 5+ years in biopharma operations, and experience with audits. Hybrid work model and global regulatory readiness are core priorities.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline; advanced degree preferred.
• Minimum of 5 years’ experience in biopharmaceutical operations or equivalent.
• Experience with internal and health authority audits, particularly pre-licensure inspections.

Responsibilities

• Supports validation activities for new products or processes at the Leiden CTF.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Performs data analysis and prepares protocols, reports and summaries for validation.
• Designs and executes test plans and risk mitigation activities for investigations.
• Interfaces with process engineers and serves as process validation SME.
• Leads site Change Controls and supports lifecycle management changes.

Skills

cGMP knowledge

Process validation

Data analysis

Communication skills

Biopharmaceuticals

Education

Bachelor’s degree in science, engineering, biochemistry or related discipline

Advanced degree preferred

Tools

APS/APV

PPQ

Job description

Bristol Myers Squibb Netherlands is seeking a Senior Specialist, MSAT Validation & LCM to provide validation and lifecycle support at the Leiden Cell Therapy Facility. You will participate in facility, process and aseptic validation activities, work on tech transfers, and support lifecycle changes with cross-functional teams.

Role requires strong cGMP knowledge, 5+ years in biopharma operations, and experience with audits. Hybrid work model and global regulatory readiness are core priorities.