Cleanroom Assembler

The Cleanroom Assembler is responsible for fabricating, inspecting, and packaging MaxCyte's Process Assembly (PA) Disposables and Sub-assemblies in a controlled cleanroom environment. This position performs assembly operations using engineering drawings, manufacturing documentation, and established procedures while maintaining compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), Manufacturing Batch Records, and the Quality Management System (QMS). The incumbent works collaboratively with team members to ensure the highest levels of product quality, productivity, safety, and continuous improvement.

Essential Duties and Responsibilities

• Fabricate and package Process Assembly (PA) Disposables and Sub-assemblies following engineering drawings, written assembly instructions, manufacturing documentation, and verbal instructions.
• Read, understand, and follow established manufacturing procedures and work instructions.
• Accurately document manufacturing activities using Good Documentation Practices (GDP).
• Perform all duties within the cleanroom while adhering to gowning requirements and wearing approved Personal Protective Equipment (PPE).
• Comply with Good Manufacturing Practices (GMP), including proper material handling, labeling, segregation, and traceability requirements.
• Utilize hand tools and production equipment such as cutting tools, solvent bonding dispensers, packaging sealers, and other assembly-related equipment.
• Conduct visual inspections for particulates and perform in-process inspections to ensure product quality and compliance.
• Maintain the highest standards of workmanship, quality, and productivity.
• Execute manufacturing activities in accordance with Standard Operating Procedures (SOPs), Manufacturing Batch Records, and Quality Management System requirements.
• Support and participate in investigations, corrective actions, and quality-related activities as directed.
• Identify and recommend improvements to manufacturing processes, documentation, equipment, and workflow efficiencies.
• Work cooperatively and professionally with cross-functional teams and fellow employees.
• Participate in daily, weekly, and monthly cleanroom cleaning, housekeeping, and preventive maintenance activities.
• Carry out assignments safely and efficiently while adhering to all company policies, procedures, and safety requirements.
• Comply with all applicable health, safety, environmental, and regulatory requirements.
• Perform other duties and responsibilities as assigned.

PId25589fdaf9d-38059-41257262