Senior Aseptic Process Validation Engineer, Cell Therapy

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

Job summary

VetJobs seeks a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy for the Devens facility. This on-site role supports aseptic validation programs and regulatory readiness, working Monday to Friday. Requires a science-based degree and at least 2 years in biopharma operations.

Responsibilities include leading validation efforts, authoring protocols and reports, and coordinating cross-functional teams to ensure GMP compliance and readiness for inspections.

Qualifications

• Experience in cGMPs and multinational biopharmaceutical regulations.
• Experience in aseptic processing/validation and facility/clean room design.
• Experience with internal and health authority audits.
• Excellent verbal/written communication skills.

Responsibilities

• Support the execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.
• Author qualification/validation documents (e.g. procedures, protocols and summary reports) and ensure 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.

Skills

cGMP Regulations

Aseptic Processing

Audits

Communication Skills

Education

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

High School/GED

Job description

VetJobs seeks a Senior Specialist, Associate Aseptic Process Validation Engineer, Cell Therapy for the Devens facility. This on-site role supports aseptic validation programs and regulatory readiness, working Monday to Friday. Requires a science-based degree and at least 2 years in biopharma operations.

Responsibilities include leading validation efforts, authoring protocols and reports, and coordinating cross-functional teams to ensure GMP compliance and readiness for inspections.