Validations Specialist

📋 Description

• • Join Rapid Micro Biosystems (RMB), a pioneering company at the forefront of revolutionizing healthcare product development, and play a pivotal role in accelerating the delivery of life-saving innovations to a global market. At RMB, we are driven by a singular mission: to win the race against time in bringing new healthcare products safely to those who need them. Our cutting-edge, automated systems are transforming the pharmaceutical industry, and your career here will place you at the nexus of diverse, world-class teams specializing in robotics, artificial intelligence, machine learning, advanced imaging, and microbiology.
• • As a Validation Specialist, you will be an integral part of our Global Customer Support Team, a critical function that ensures the seamless integration and optimal performance of our groundbreaking automated systems at customer sites. Your primary responsibility will be the meticulous execution of validation protocols, a cornerstone of our commitment to quality and regulatory compliance. This includes conducting Installation Qualifications (IQ) and Operational Qualifications (OQ) to verify that our systems are installed correctly and function according to design specifications. You will also be responsible for Performance Qualifications (PQ), ensuring that the systems consistently meet the required performance standards under real-world operating conditions.
• • Beyond protocol execution, you will provide essential support throughout the Method Qualification process, a crucial phase where customers validate their specific testing methods using our automated platforms. Your expertise will guide customers in successfully demonstrating the efficacy and reliability of their processes, thereby accelerating their product release timelines.
• • This role extends to the development and refinement of our internal documentation. You will be tasked with writing and revising Standard Operating Procedures (SOPs) and other critical validation documents. This involves ensuring that our documentation is clear, concise, accurate, and compliant with relevant industry regulations and quality standards. Your contributions will directly impact the efficiency and consistency of our validation processes globally.
• • A vital aspect of your role will be to act as a conduit for customer feedback. You will meticulously document insights, suggestions, and any issues raised by our customers. This feedback is invaluable, providing us with direct input to enhance our products, services, and support offerings, ensuring we remain at the cutting edge of the industry and continue to meet and exceed customer expectations.
• • Furthermore, you will serve as a technical expert during the sales process. Your deep understanding of our automated systems and their validation requirements will be crucial in supporting our sales team. You will engage with prospective clients, articulate the technical capabilities and benefits of our solutions, and address their specific validation concerns, helping to build confidence and secure new business opportunities.
• • This position demands a high degree of autonomy and a proactive approach to problem-solving. You will be expected to manage your time effectively, prioritize tasks, and work independently while collaborating with cross-functional teams, including R&D, Engineering, Sales, and Customer Support. Your ability to communicate complex technical information clearly and concisely to diverse audiences, both internally and externally, will be paramount.
• • The fast-paced nature of RMB is fueled by our high growth trajectory, characteristic of a world leader in microbiology automation. We foster an environment where you can achieve your personal career goals and cultivate your passions. Advancement at RMB offers unparalleled opportunities for professional development, skill enhancement, and the chance to make a profound impact on our business. You will do more, learn more, and contribute significantly to our ongoing success.
• • This role requires a commitment to travel, with up to 80% of your time spent across North America, Europe, and Asia. Typical assignments will last approximately one week, though occasional longer assignments may be necessary to support critical customer projects. This extensive travel provides a unique opportunity to experience different markets, build strong international relationships, and witness firsthand the global impact of our technology.
• • We are looking for an individual who is not only technically proficient but also possesses excellent interpersonal skills, a strong work ethic, and a dedication to quality and customer satisfaction. If you are eager to contribute to a dynamic, innovative company that is making a real difference in healthcare, we encourage you to apply.