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.
Education:
- High School Diploma or equivalent required.
- Ability to read, write, comprehend, and follow written and verbal instructions in English.
Experience:
- 0-2 years of manufacturing, production, assembly, or cleanroom experience required.
- Experience with manual assembly operations and manufacturing processes preferred.
- Experience working in a GMP-regulated environment preferred.
- Experience documenting work according to GDP requirements preferred.
Technical Skills:
- Basic computer proficiency, including Microsoft Office applications.
- Ability to read and interpret engineering drawings, assembly instructions, and manufacturing documentation.
- Ability to accurately complete production documentation and records.
Knowledge, Skills, and Abilities:
- Strong attention to detail and commitment to quality.
- Ability to perform repetitive assembly tasks with a high degree of accuracy.
- Ability to perform manual dexterity tasks involving small components and parts.
- Ability to identify defects and particulates through visual inspection.
- Ability to multitask and work effectively in a fast-paced manufacturing environment.
- Strong organizational and time-management skills.
- Ability to work independently with minimal supervision and as part of a team.
- Demonstrated commitment to safety, quality, and continuous improvement.
Physical Requirements:
- Ability to safely lift and carry up to 38 pounds.
- Ability to stand or sit for extended periods of time.
- Ability to perform repetitive hand and finger movements required for assembly operations.
- Ability to maintain 20/20 corrected or uncorrected vision sufficient to identify particulates, defects, and small components.
- Ability to work for extended periods while wearing cleanroom garments and PPE.
- Must be able to work within a controlled cleanroom environment.
- · Must be a non-smoker
Working Conditions:
- Controlled cleanroom manufacturing environment.
- Required use of approved cleanroom garments and PPE.
- Exposure to routine manufacturing equipment and materials in accordance with established safety procedures.
Core Competencies:
- Quality Focus
- Attention to Detail
- Teamwork and Collaboration
- Accountability
- Continuous Improvement
- Safety Awareness
- Effective Communication
- Reliability and Dependability
MaxCyte offers a base salary, annual bonus, and equity. MaxCyte also offers a comprehensive benefits package including health, dental, vision, life, and disability insurance and generous time off.
MaxCyte is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status
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