Manufacturing Engineer

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:

Are you a passionate engineer looking to apply your skillset in bringing capable and scalable processes into a GMP environment?

Rapid Micro Biosystems is looking for a New Product Manufacturing Engineer I/II who will be responsible for the design transfer of new products to our manufacturing facility. This position is vital to the Operations organization to ensure that highly capable processes will be implemented for our new products. The successful candidates excel at problem-solving skills and can manage complex projects within a cross-functional team.

Responsibilities will also include other upstream activities such as capital equipment, facility requirements, existing and emerging manufacturing technologies, tool design, cost estimating, and configuration control.

ROLES & RESPONSIBILITIES:

·       Participate in New Product Development teams and represent Operations.

·       Participate in the development of robust, scalable, and high-quality solutions for new products in the cGMP environment.

·       Lead specific deliverables within the Design Transfer process and ensure adherence to the project timeline.

·       Lead the root-case and corrective action response and countermeasure implementation for production issues, product defects, customer complaints, and any other technical challenge that may arise, for new products.

·       Identify and implement opportunities to improve existing processes, equipment, systems, and infrastructure by leveraging and setting industry best practices.

·       Generate and modify manufacturing process documentation.

·       Train and/or provide work instructions to operators/technicians.

EDUCATION & QUALIFICATIONS:

The following education and experience are required:

·       Bachelor’s or Master’s degree in Engineering is required.

·       3+ years of manufacturing\process engineering experience required.

·       2+ years of experience bringing new designs/processes into a GMP environment

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.

·       Work with vendor/suppliers to design, procure, and fabricate equipment tooling and fixtures.

·       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

·       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.

·       This is not a remote or hybrid-remote position, in-person attendance is expected.

Occasional off-shift or weekend work may be required to support project and production timeline.

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.