Validations Specialist

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. The role will involve up to 80% travel within North America with occasional travel to the Europe and Asia. 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 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. Originally posted on Himalayas