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
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