Senior MSAT Validation & LCM Specialist

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 provide process validation and lifecycle management support at the Leiden Cell Therapy Facility. You will participate in facility, process, and aseptic validation activities, including tech transfers, and support lifecycle changes at the site.

Join a collaborative team focused on compliance with cGMP and global regulatory expectations, performing data analyses, risk assessments, CAPAs, and site Change

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related field; advanced degree preferred.
• Minimum 5 years’ experience in biopharmaceutical operations.
• Proficient in cGMPs and multinational biopharmaceutical regulations.
• Experience with process validation and lifecycle management.

Responsibilities

• Supports validation activities for new products or processes at the Leiden CTF.
• Performs data analysis, including statistics, and prepares reports and summaries for validation and lifecycle management.
• Design and execute test plans and risk mitigation activities as part of investigations.
• Interface with process engineers and serve as validation SME.
• Supports site implementation of Lifecycle Management changes and equipment commissioning.
• Leads/owns site Change Controls and participates in facility risk assessments.
• Ensures compliance with regulatory expectations and supports inspections.
• Contributes to continuous improvements reducing costs and lead times.

Skills

cGMP knowledge

Process validation

Lifecycle management

Audits and regulatory inspections

Data analysis and statistics

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry or related

Advanced degree preferred

Tools

Statistics

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 participate in facility, process, and aseptic validation activities, including tech transfers, and support lifecycle changes at the site.

Join a collaborative team focused on compliance with cGMP and global regulatory expectations, performing data analyses, risk assessments, CAPAs, and site Change