Assistant Process Engineer

Columbia Consulting Group is seeking an Associate Process Engineer for their Devens Cell Therapy Facility. This role focuses on assessing process-related deviations, analyzing performance data, and providing technical support to cross-functional teams while ensuring compliance with GMP standards. 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 Skills 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 Proficiency with data monitoring and analysis tools Strong presentation and communication skills Ability to verify data accuracy across multiple GMP systems Experience in assessing process-related deviations and providing clear, data-driven evaluations Ability to analyze process performance data to identify trends and improvement opportunities Ability to summarize and present findings effectively to audiences with varying levels of technical understanding Ability to provide on-the-floor technical support for equipment and process-related issues Ability to assist in deviation prevention and closure through site quality systems Ability to collaborate with cross-functional teams including Scheduling, MSAT, Supply Chain, Quality, and Facilities & Engineering Ability to apply continuous improvement tools to identify and close procedural and compliance gaps Ability to perform gowning activities and enter manufacturing areas as needed 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 Company Overview Columbia Consulting Group is a consulting company located in Columbia. It was founded in 1973, and is headquartered in Columbia, Maryland, USA, with a workforce of 2-10 employees. Its website is