Assistant Process Engineer

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

• 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.

Required Qualifications

• 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.