Rapid Micro Biosystems

Validations Specialist

Posted 14 Hours Ago

Be an Early Applicant

4 Locations

Remote

70K-85K Annually

Junior

Biotech

The Role

Execute installation, operation, and performance qualification protocols for automated microbiology systems; write/revise SOPs and validation documents; support method qualification; document customer feedback; act as technical expert during sales; frequent onsite validation and customer engagements.

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.

As a part of the RMB Global Customer Support Team, the Validation Specialist is responsible for execution of validation protocols for a cutting edge, automated system, including Installation/Operation Qualifications, Performance Qualifications, and support throughout the Method Qualification process. Additional responsibilities include writing/revising SOPs and validation documents, documenting customer feedback, and contribute as the technical expert during the Sales process.

This role requires up to 80% travel across North America, Europe, and Asia. Typical trips last approximately one week, with occasional longer assignments.

The anticipated start date for this role is Monday, July 6.

Basic Qualifications

Bachelor's Degree is Life Sciences Discipline
2+ years of experience in the pharmaceutical industry in either Microbiology QC Labs or Validation

Preferred Qualifications

Strong technical writing, verbal communication, and presentation skills
Excellent problem solving and troubleshooting skills
Experience and competence in a range of microbiological methods
Knowledge of GxPs
Knowledge of 21 CFR Part 11 and Annex 11
Enthusiastic, detail oriented, and capable of working independently as well as working within a cross-functional team
Proficient in Microsoft Office including Word, Excel, and PowerPoint
Ability to form dependable and professional relationships with customers
Project Management experience is a plus

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 $70,000-$85,000

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.

Top Skills

21 Cfr Part 11

Annex 11

Gxp

Microbiological Methods

Excel

Microsoft Powerpoint

Microsoft Word

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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