Senior Validation Engineer - GMP Process Automation

Bristol-Myers Squibb; Harvard (MA); On-site; USD 93,000 - 112,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible Time Off

11 paid holidays

Global Shutdown

Job summary

Bristol Myers Squibb seeks a Senior Validation Engineer to qualify process control and MES systems in a GMP biologics facility. You will oversee protocol generation, execution, issue resolution, and approval of qualification activities to ensure readiness for use and regulatory compliance.

The role involves coordinating validation for DeltaV and Syncade, supporting operations, and leading technical writing and project management efforts in a highly automated environment.

Qualifications

• Knowledge of biopharmaceutical processing and validation.
• Experience with GMP/regulated environments (FDA/EU).
• Ability to manage validation projects and write technical reports.

Responsibilities

• Validate operation of GMP manufacturing systems (Process Automation and MES).
• Manage test protocol generation, execution, issue resolution and report approvals.
• Coordinate validation activities with change controls and revalidation programs.
• Provide validation support to multi-function teams and advise operations.

Skills

Process validation

Project management

Technical writing

Regulatory compliance

Communication

Education

BS in engineering (chemical preferred)

Tools

DeltaV

Syncade

DCS/PLC

Job description

Bristol Myers Squibb seeks a Senior Validation Engineer to qualify process control and MES systems in a GMP biologics facility. You will oversee protocol generation, execution, issue resolution, and approval of qualification activities to ensure readiness for use and regulatory compliance.

The role involves coordinating validation for DeltaV and Syncade, supporting operations, and leading technical writing and project management efforts in a highly automated environment.