About this role
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization through trusted partnership, recognized industry expertise, and proven regulatory track record. The Manufacturing Technician II is accountable for results in a fast-paced environment and assists with manufacturing sterile injectable products in vial and syringe configurations for clinical/commercial distribution. This key role executes advanced production tasks involving compound, fill, and finish processes via aseptic isolator technology.
The Manufacturing Tech II performs operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). Employs acceptable techniques while working in manufacturing environments, including PPE gowning. Conducts in-process sampling, weight checks, component counting, and basic math calculations, along with visual inspections.
This 100% on-site position operates on 3rd shift Sunday through Thursday from 11:00pm to 7:30am in a high-compliance environment requiring technical expertise in aseptic processes with single-use components. The role demands ability to troubleshoot and maintain quality under GMP. Works occasional hours outside scheduled shift based on business needs, fostering a safety-first culture.
Technicians learn specific department procedures, gain general understanding of Good Documentation Practices (GDP) and GMP, and follow directions from leadership and peers to meet manufacturing goals. Identifies inefficiencies for continuous process improvement and escalates real-time to supervision. Opportunity to become subject matter expert (SME) on compounding/filling processes and equipment.
Requirements
- High level of technical expertise in aseptic processes requiring single-use components
- Ability to troubleshoot manufacturing processing equipment
- General understanding of Good Documentation Practices (GDP) and GMP
- Ability to learn specific department procedures and follow directions from leadership/peers
- Employs acceptable techniques in manufacturing environments, including PPE gowning
- Performs basic math calculations for in-process sampling, weight checks, and component counting
- Demonstrates technical ability in general manufacturing technologies per SOPs and cGMPs
Responsibilities
- Learns and executes manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection
- Becomes a subject matter expert (SME) on compounding/filling processes and equipment
- Performs production processes with adherence to SOPs, batch records, quality standards
- Conducts in-process and end-of-process sampling/quality checks to ensure product standards
- Identifies inefficiencies and escalates to area supervision real-time for continuous improvement
- Maintains accurate and detailed production documentation with minimum errors
- Performs cleaning of rooms, tools, and equipment before and after use
- Assists with other manufacturing areas as required and performs activities right first time
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