Validations Specialist

Overview

Validations Specialist at Rapid Micro Biosystems

Rapid Micro Biosystems (RMB) is a leader in microbiology automation. RMB develops and services products for fast, accurate detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The Growth Direct system automates rapid compendial QC Micro testing to ensure data integrity, compliance, and operational efficiency.

Responsibilities

• Execute validation protocols for automated systems, including Installation/Operational Qualifications, Performance Qualifications, and support throughout the Method Qualification process.
• Write and revise SOPs and validation documents; document customer feedback.
• Act as a technical expert during the Sales process.
• Travel up to 80% within North America with occasional travel to Europe and Asia.

Qualifications

• Basic Qualifications:
  • Bachelor's Degree in Life Sciences or a related 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, 21 CFR Part 11 and Annex 11.
  • Enthusiastic, detail oriented, and capable of working independently or within a cross-functional team.
  • Proficient in Microsoft Office (Word, Excel, 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 Growth Direct system automates rapid compendial QC Micro testing to drive data integrity, compliance, and operational efficiencies. RMB is headquartered in Lexington, MA, with R&D and manufacturing in Lowell, MA, and field offices in Freising (Germany), Switzerland, and Singapore.

Equal Opportunity

Rapid Micro Biosystems is committed to equal employment opportunity. Applications and employees are evaluated on individual qualifications. RMB does not discriminate on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, health insurance status, marital status, age, veteran status, or other bases prohibited by law.

Employment details

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Quality Assurance

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