- Project Management
- Microsoft Word
- Microsoft Office
- Communication Skills
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.
Bachelor's degree in Life Science discipline
2+ years of experience in the pharmaceutical industry in either Microbiology QC Labs or Validation
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 (www.rapidmicrobio.com) provides innovative products for faster detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products.
The Company's Growth DirectTM System detects contamination earlier, delivering compelling economic benefits to manufacturers, while improving their quality process. The Growth Direct System is the first and only automated system that addresses all key microbial QC applications and fits with current regulatory practices, a critical accelerator for adoption. Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering significant cost savings and increased operational efficiency. We are headquartered in Lowell, MA with operations in Lowell and Freising, Germany.
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, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.
Must be authorized to work in the U.S. Please no phone calls or agencies please.