Senior Validation Engineer - GMP Systems & DeltaV Expert

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

Benefits offered by this job

Comprehensive benefits

Flexible Time Off (FTO)

11 paid holidays

Volunteer days

Job summary

Bristol Myers Squibb, Devens, MA, is seeking a Senior Specialist, Validation Engineer - CSV, to qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (Syncade) and ensure readiness for intended use under GMP compliance.

You will manage test protocols, execute validation activities arising from change controls and capital projects, and provide technical writing and project-management support across multi-function teams.

Qualifications

• 2+ years of experience developing and/or testing process automation system software (DeltaV batch preferred).
• Experience with large-scale distributed control systems.
• B.S. in engineering or related discipline (chemical preferred).
• Understanding of SOPs, cGMPs and regulatory guidelines (FDA, EU).

Responsibilities

• Qualify operation of GMP manufacturing systems (Process Automation, MES) in a highly automated biologics facility.
• Manage test protocol generation, execution, issue resolution and summary report approvals for DeltaV.
• Manage test protocol generation, execution, and approvals for Syncade MES configuration changes.
• Perform assessment and execution of validation work arising from change controls, capital projects, shutdowns, and revalidation programs.
• Act as a point of contact for project stakeholders and provide validation support to multi-functional teams.
• Ensure alignment with BMS directives and industry guidelines on validation.

Skills

Process validation

DeltaV batch

GMP compliance

Project management

Technical writing

Regulatory understanding

Communication skills

Lean principles

Education

Bachelor's degree in Engineering (chemical preferred)

Tools

DeltaV

Syncade

DCS

PLC

Job description

Bristol Myers Squibb, Devens, MA, is seeking a Senior Specialist, Validation Engineer - CSV, to qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (Syncade) and ensure readiness for intended use under GMP compliance.

You will manage test protocols, execute validation activities arising from change controls and capital projects, and provide technical writing and project-management support across multi-function teams.