Rapid Micro Biosystems

Manufacturing Engineer II

Reposted 12 Days Ago

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Lowell, MA, USA

In-Office

93K-103K Annually

Junior

Biotech

The Role

The Manufacturing Engineer II will optimize automated production equipment, troubleshoot systems, drive down downtime, and ensure compliance with quality standards.

Summary Generated by Built In

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.

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 PLC programming (Allen-Bradley, Siemens, etc.).
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 AutoCAD, SolidWorks for mechanical adjustments.
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.

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.

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The Company

HQ: Lowell, Massachusetts

230 Employees

Year Founded: 2006

What We Do

Rapid Micro Biosystems is an innovative life sciences technology company providing mission-critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. We are the trusted partner in quality control microbiology automation, enabling our customers to improve and save lives. This vision has been realized with the development of the Growth Direct® System. Our Growth Direct® platform automates and modernizes the antiquated, manual quality control microbiology testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct® platform brings the quality control lab to the manufacturing floor, unlocking the power of in-line/at-the-line QC automation to deliver faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. Our company values guide us in our vision: Customer Driven – We are committed to providing our customers with the highest quality products and services Respect – We welcome and embrace our differences to create a trusting environment Grit – We are determined to turn challenges into successes. One RMB – We operate as one team, committed to our shared purpose. The company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, and global locations in Switzerland, Germany, and the Netherlands