Sr Specialist, Associate Aseptic Process Validation - Devens MA

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

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. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is On-Site at the location detailed in the job post.

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

Auto req ID

479350BR

Minimum Education Required

High School/GED

Job_Category

Analyst

Additional Qualifications/Responsibilities

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

BMSCART

GPS_2026

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview

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

City*

Devens

State*

Massachusetts

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

>$100,000