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.
GENERAL DESCRIPTION:
The Manufacturing and Automation Engineer I 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 productivity and uptime. The involvement will include designing/executing characterization studies, analyzing results, and refining engineering designs.
The responsibilities will also include other upstream activities such as installing and validating new equipment, characterizing and documenting processes, and assisting operators with complicated maintenance activities.
Occasional off-shift or weekend work may be required to support production.
ROLES & RESPONSIBILITIES:
•Complete projects to optimize productivity and uptime of the production equipment.
•Design and/or execute studies to characterize process parameters.
•Monitor daily performance data for trends and actions to prevent potential issues on production equipment.
•Participate in the root-case and corrective action response and countermeasure implementation for production issues, product defects, and other technical challenges that may arise throughout normal operations.
•Identify and implement opportunities to improve existing processes, equipment, systems, and infrastructure by leveraging and setting industry best practices.
•Train and/or provide work directions to operators/technicians.
•Maintain and update manufacturing process documentation to reflect current best practices.
EDUCATION & QUALIFICATIONS:
The following education and experience are required:
•Higher education in Engineering is required.
•1 years of engineering experience is required.
•Experience in GMP environment is required.
The following qualifications are necessary for a successful candidate:
•Ability to work within a highly collaborative team and as an individual contributor in a fast-paced, changing environment.
•Ability to leverage and/or engage others to accomplish projects.
•Strong verbal and written communications with the ability to effectively communicate at multiple levels across different shifts in the organization.
•Strong organizational and follow-up skills, as well as attention to detail.
•Ability to maintain regular and predictable attendance.
•Understand engineering principles, theories, concepts, practices, and techniques.
PREFERRED EXPERIENCES & SKILLS:
•Equipment and process validation experience in medical device or other regulated industry.
•Utilize statistical tools like Gage R&R, Cp, Cpk, and Statistical Process Controls.
•Understand manufacturing and problem-solving concepts like Value Stream mapping, 6S, and A3 to improve quality, labor efficiency, throughput, and ensuring the root cause of problem is identified and quickly resolved.
•Experience with automated or robotic equipment and systems.
WORKING CONDITIONS/PHYSICAL DEMANDS
•This is not a remote or hybrid-remote position, in-person attendance is expected.
•Must be able to read, write, and communicate in English.
•Close visual acuity to work on a computer and to determine the accuracy, neatness, and thoroughness of work.
•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.
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.