Assistant Process Engineer

Pay Rate: $29.25
Job Description: 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 areas.

Key Responsibilities

Assess the impact of process-related deviations and provide clear, data-driven evaluations.
Analyze process performance data to identify trends and improvement opportunities; experience with data monitoring systems such as Tableau, Spartan, and Mareana is a plus, as well as proficiency in Excel and JMP for data analysis.
Assess trends in support calls received from the manufacturing floor to identify problem areas with the process and recommend solutions.
Summarize and present findings effectively to audiences with varying levels of technical understanding; strong presentation and communication skills are essential.
Verify data accuracy across multiple GMP systems; maintain strong understanding of GMP data systems and move swiftly between platforms.
Provide on-the-floor technical support for equipment and process-related issues.
Assist in deviation prevention and closure through site quality systems.
Collaborate with cross-functional teams including Scheduling, MSAT, Supply Chain, 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.
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Basic Qualifications
Required Bachelors degree in Science or Chemical/Biological Engineering.
Minimum 02 years of industry experience; cGMP or Cell Therapy manufacturing experience preferred.
Proficiency in Excel and JMP for data analysis;

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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.
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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.
Additional Job Requirements:
None