Sr Specialist, Associate Aseptic Process Validation - Devens MA

Military Spouse Corporate Career Network • Devens, MA

1d • Onsite

About The Position

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

Requirements

• 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
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior