Sr Specialist, Associate Aseptic Process Validation - Devens, MA

VetJobs; Harvard (MA); On-site; USD 87,660 - 106,224; Full time

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Senior Specialist, Associate Aseptic Process Validation Engineer within Cell Therapy to support APS/APV and validation documentation. This on-site role requires collaboration with cross-functional teams to ensure GMP readiness.

The candidate will lead aseptic risk assessments, author summary reports, and support regulatory inspections. A BS degree with 2+ years in biopharma is required, along with strong communication skills.

Qualifications

• Bachelor’s degree in science, engineering, biochemistry or related discipline.
• Minimum of 2 years’ experience in biopharmaceutical operations.
• Experience in cGMPs and multi-national biopharmaceutical/cell therapy regulations.
• Experience in aseptic processing/validation.
• Experience with internal and health authority audits.

Responsibilities

• Support the execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
• Author qualification/validation documents (procedures, protocols, reports) and ensure Manufacturing readiness for APS execution.
• Lead aseptic risk assessments and author associated summary reports.
• Author product impact assessments for Personnel and Environmental Monitoring-related deviations.
• Lead/Own site Change Controls and support investigations and global change controls.

Skills

cGMP knowledge

Aseptic processing

Audits

Communication

Education

Bachelor's degree in science/engineering/biochemistry or related discipline

Job description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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

Additional Qualifications/Responsibilities

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

City: Devens

State: Massachusetts

Job Code: Pharmaceutical Pharmaceutical

Affiliate Sponsor: Bristol Myers Sqibb BMS