Senior Specialist, Associate Aseptic Process Validation Engineer
Bristol Myers Squibb
Summary
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).
Job description
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
Requirements
- 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
- 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
Benefits
- Wellbeing support
- Retirement benefits
- Financial protection benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Flexible Time Off
- Paid company holidays
- Paid sick leave
- Paid volunteer days
- Summer hours flexibility
- Leaves of absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.