Assistant Process Engineer

Project overview

Job Description

We are seeking a Senior Specialist, MS&T Validation to support process validation activities at a Cell Therapy Facility (CTF) in Devens, MA. The candidate will support facility, process, and aseptic validation activities, Aseptic Process Validations (APV), and process lifecycle management changes.

Key Responsibilities

Required Qualifications

Job Facts: Contract W2 | 12 Months | On-site | $32 - $35/hr

Skills: Cell Therapy Facility, Aseptic Process Simulations, current Good Manufacturing Practices (cGMP), biopharmaceutical operations, therapy manufacturing and validation practices.

Reference: Dice Id: 90944144 | Position Id: 9125080

• Support and oversee process validation activities within the Cell Therapy Facility.
• Participate in Aseptic Process Simulations (APS/APV) and other validation activities.
• Support process lifecycle management changes.
• Prepare validation protocols, reports, and technical summaries.
• Ensure compliance with current Good Manufacturing Practices (cGMP).
• Maintain inspection readiness and follow applicable safety and quality requirements.
• Bachelor s degree in Science, Engineering, Biochemistry, or a related discipline.
• Minimum of 2 years of experience in biopharmaceutical operations or equivalent experience.
• Knowledge of cGMP requirements and multinational biopharmaceutical or cell therapy regulations.
• Strong written and verbal communication skills.
• Experience or familiarity with process validation and aseptic validation activities is beneficial.

Project details

• Start: flexible
• Duration: 12 Months
• Remote: onsite
• Location: Devens, MA, US, US