Senior Validation Engineer - Biopharma Automation

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

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Wellbeing support

Job summary

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer - CSV to qualify and support the configuration of Process Control System (DeltaV) and MES (Syncade) for GMP biologics manufacturing at the Devens facility in MA.

You will manage test protocols, execute validation tasks, coordinate change controls, and advise operations on validation matters, ensuring compliance with SOPs, cGMPs, and regulatory expectations across FDA/EU frameworks.

Qualifications

• Knowledge of biopharmaceutical processing with at least 2 years developing/testing process automation software (DeltaV batch).
• B.S. in engineering (chemical preferred) or related field.
• Experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Understanding of SOPs, cGMPs and other regulatory guidelines (FDA, EU).
• DCS and PLC experience in the pharmaceutical industry.

Responsibilities

• Validate GMP manufacturing systems operation (Process Automation System, MES) in a highly automated biologics facility.
• Manage test protocol generation, execution, issue resolution and report approval for DeltaV changes.
• Manage test protocol generation, execution, issue resolution and report approval for Syncade changes.
• Assess validation work and execute validation arising from changes, capital projects, and revalidation programs.
• Serve as a point of contact for project stakeholders and provide validation support to cross-functional teams.
• Ensure alignment with directives and industry guidelines on validation.
• Duties may include internal compliance or efficiency improvement efforts.

Skills

Process validation

DeltaV

Technical writing

Project management

Education

B.S. in Engineering

Tools

DeltaV

Syncade

DCS/PLC

Job description

Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer - CSV to qualify and support the configuration of Process Control System (DeltaV) and MES (Syncade) for GMP biologics manufacturing at the Devens facility in MA.

You will manage test protocols, execute validation tasks, coordinate change controls, and advise operations on validation matters, ensuring compliance with SOPs, cGMPs, and regulatory expectations across FDA/EU frameworks.