Associate Process Engineer

Job Title :
Associate Process Engineer
Job  : 25-11941
Location:
Devens, MA
Duration: 06 months on W2 contract (possibility of extension)

50% onsite required

Work Schedule:

Mon-Fri(normal business hours)

Position Summary
Associate Process Engineer role is based at Devens Cell Therapy Facility (CTF). This role is responsible for assessing process-related deviations, analyzing performance data to identify trends and improvement opportunities, and providing technical support to cross-functional teams. The position requires proficiency with data monitoring and analysis tools, strong presentation and communication skills, and the ability to verify data accuracy across multiple GMP systems.

Additional duties include assisting in deviation prevention and closure, applying continuous improvement tools, and performing gowning activities to enter manufacturing area s.

Quality, and Facilities & Engineering.

• Apply continuous improvement tools to identify and close procedural and compliance gaps.

• Perform gowning activities and enter manufacturing areas as needed.

• This position offers growth opportunities to expand into trend investigations using statistical tools (e.g., EWMA, control charts) and evaluating manufacturing capabilities for continuous improvement.

Basic Qualifications

• Required Bachelor's degree in Science or Chemical/Biological Engineering.

• Minimum 0–2 years of industry experience; cGMP or Cell Therapy manufacturing experience preferred.

• Proficiency in Excel and JMP for data analysis;

Preferred Skills

• Experience with Tableau, Spartan, and Mareana is a plus.

• Strong technical understanding of cell therapy manufacturing processes.

• Familiarity with GMP documentation and electronic data systems.

• Technical writing skills for authoring impact assessments, SOPs, and clear documentation.

• Ability to work collaboratively in a fast-paced environment.

• Strong problem-solving, troubleshooting, and presentation skills.

Working Conditions

• Office-based role with occasional entry into GMP manufacturing areas.

• Ability to perform gowning activities and comply with cleanroom requirements.

• Exposure to strong magnetic fields and hazardous materials in manufacturing areas.