Senior Specialist, Associate Aseptic Process Validation Engineer

Bristol-Myers Squibb Company; Harvard (MA); Presencial; USD 88.000 - 106.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible Time Off

11 company holidays

Paid vacation

Descripción de la vacante

Bristol Myers Squibb is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy to support the Devens Cell Therapy Facility. The role focuses on aseptic validation programs, qualifications, and risk assessments within a GMP environment.

Responsibilities include authoring validation documents, participating in site change controls, and ensuring regulatory inspection readiness as a subject matter expert.

Formación

• Experience in cGMPs and multinational biopharmaceutical regulations.
• Experience in aseptic processing/validation and clean room design.
• Experience with internal and health authority audits.

Responsabilidades

• Support APS/APV execution and aseptic validation activities.
• Author qualification/validation documents and ensure manufacturing readiness for APS.
• Lead aseptic risk assessments and summarize reports.

Conocimientos

cGMP compliance

Aseptic processing/validation

Regulatory audits

Communication skills

Educación

Bachelor’s degree in science/engineering/biochemistry

Descripción del empleo

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy provides process aseptic validation support to the Devens Cell Therapy Facility (CTF). The Senior Specialist supports the aseptic process validation program for the Devens Cell Therapy Facility (CTF).

Shifts Available

Monday – Friday, Standard Working Hours

Responsibilities

• Responsible for supporting the execution of Aseptic Process Simulations/ Validations (APS/APV) and Aseptic Performance Qualifications.
• Authors qualification/validation documents (e.g. procedures, protocols and summary reports) and ensures Manufacturing readiness for APS execution.
• Participates in/Leads aseptic risk assessments and authors associated summary reports.
• Authors product impact assessments for Personnel and Environmental Monitoring-related deviations.
• Leads/Owns site Change Controls as required
• Supports investigations and global change controls as required
• Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert.
• Serves as a MS&T representative on cross-functional and multi-site teams
• Builds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs

Knowledge and Skills

• Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Experience in aseptic processing/validation and facility/clean room design.
• Experience with internal and health authority audits
• Excellent verbal/written communication skills

Basic Requirements

• Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required
• A minimum of 2 years’ experience in biopharmaceutical operations, or its equivalent is required

Compensation Overview

Devens - MA - US: $87,660 - $106,224

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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in 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/.

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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.

R1604616 : Senior Specialist, Associate Aseptic Process Validation Engineer