Sunrise Systems, Inc. · 3 weeks ago
Assistant Process Engineer
Sunrise Systems, Inc. is seeking an Associate Process Engineer for their Devens Cell Therapy Facility. The role involves assessing process-related deviations, analyzing performance data, and providing technical support to cross-functional teams while ensuring data accuracy in GMP systems.
Information Technology & Services
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
Qualification
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
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
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase