Manufacturing Engineer II

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today’s innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky’s the limit. Careers at RMB are fast-moving, with the high growth you’d expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You’ll do more, learn more, and have the ability to make a profound impact on our business. The Manufacturing Engineer II will have responsibility to support the day-to-day operation of automated production equipment at RMB, Lowell. This position requires mechanical skills and must be able to work in an ISO 8 cleanroom. This individual will work closely with other engineers in the team to optimize Yield and Uptime for our production equipment. Rapid Micro Biosystems is proud to offer a competitive total compensation package designed to attract, inspire and retain the best talent in our industry. In addition to base pay, our full-time regular employees are eligible for an attractive benefits package, cash incentive opportunities, and an equity grant. The base annual salary hiring range for this position is $100,OOO-110,000 Starting salaries are determined based on skills, experience, budget and other job-related factors. More information about our total compensation package will be shared with candidates during the recruitment process. ABOUT RAPID MICRO BIOSYSTEMS: Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation. Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes. Rapid Micro Biosystems is headquartered in Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore. Equal Opportunity: Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law. ESSENTIAL JOB FUNCTIONS Lead initiatives to reduce equipment downtime and increase yield. Troubleshoot automation systems and provide root cause analysis for equipment downtime, yield loss, and process variation. Lead and support commissioning, factory acceptance testing (FAT), site acceptance testing (SAT), and equipment validation activities. Develop and maintain technical documentation, including electrical schematics, CAD drawings, control logic diagram, standard operating procedures, and maintenance guides. Train manufacturing and maintenance personnel on automated equipment operation and basic troubleshooting. Ensure compliance with safety standards, regulatory requirements, and internal manufacturing and quality systems. EDUCATION & EXPERIENCE Bachelor’s or Master’s degree in Electrical Engineering, Automation, Mechatronics, or a related field. 2+ years of manufacturing engineering experience, preferably in the medical device or regulated industry. REQUIRED TECHNICAL SKILLS Experience in AutoCAD, SolidWorks for mechanical adjustments. Experience in machine integration, mechanical design modifications, and troubleshooting. Familiarity with cGMP and validation practices (IQ/OQ/PQ under 21 CFR Part 11, and ISO 13485). PREFERRED QUALIFICATIONS Experience in PLC programming (Allen-Bradley, Siemens, etc.). Experience in SCADA systems (e.g., FactoryTalk suite, Ignition). Experience with robotic systems or automated inspection platforms. Knowledge of FDA regulations, ISO 13485. Knowledge of HMI design tools. WORKING CONDITIONS This is not a remote or hybrid-remote position, in-person attendance is expected. Will be required to work in a cleanroom environment for extended periods. Appropriate gowning procedures will be required for access to cleanroom (hairnet, safety glasses, cleanroom apparel/lab coats, gloves). Occasional environmental odors may be present. Occasional off-shift or weekend work may be required to support production.

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      "text": "ESSENTIAL JOB FUNCTIONS",
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