Senior Specialist, Validation Engineer - CSV

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

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Principle Objective of Position: Qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (MES), which support clinical and commercial manufacturing facilities. Manage protocol generation, test execution, issue resolution and approval of qualification efforts to assure readiness for intended use to meet policy and compliance requirements.

Major Responsibilities & Duties

• Executes the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility.
• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V).
• Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade).
• Performs assessment of validation work and executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
• Executes technical work assignments as a point of contact for project stakeholders.
• Provides validation support, to multi-function teams, and advises operations on validation matters.
• Ensures alignment with BMS directives and industry guidelines on validation.

Knowledge & Skill

• Knowledge of biopharmaceutical processing including a minimum of 2 years of experience developing and/or testing process automation system software (preferably Delta V batch). Experience with large scale distributed control systems desired.
• Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
• Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Understanding of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and know how to work and manage within a regulatory environment.
• DCS and PLC based experience, preferably gained in the pharmaceutical industry.
• Understanding of lean principles is a plus.
• Project management, communication, and technical writing skills are required.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.

#LI-Onsite

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Devens - MA - US: $92,540 - $112,136

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year’s Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606185 : Senior Specialist, Validation Engineer - CSV