Maintenance Technician IV, Lead - Sterile Operations (Night Shift)

The Manufacturing Technician IV, Lead supports Filling operations. The position leads complex filling batch activities on the manufacturing floor, serves as a technical resource for the team, performs advanced-level documentation review, and resolves technical production issues. 

Job Responsibilities 

Operations 

• Lead and monitor process execution activities to ensure successful operations on the production floor. 
• Serve as a technical resource for the team; resolve complex production-related issues including batch setup, execution, technical interventions, documentation, equipment operations, and safety/quality. 
• Provide support to production technicians and mechanical technicians. 
• Apply strong organizational and problem-solving skills to make independent decisions and provide guidance to team members on daily operational activities. 
• Perform and execute filter integrity testing as needed per SOP. 
• Perform technician tasks as required, including start-up, equipment operation, batch execution, material handling, and cleaning. 
• Assemble, disassemble, and sanitize various Filling equipment. 
• Assist technical staff with preventive maintenance procedures, as required. 
• Manage inventory control and reconciliation activities using SAP. 

Documentation & Compliance 

• Perform advanced-level batch record and GMP documentation entries on the production floor, including complex or non-routine documentation; provide guidance to team members on documentation accuracy. 

Training & Development 

• Serve as a technical resource for the team, providing subject-matter support to production and mechanical technicians. 
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members. 
• Support lean activities such as performing 5S and participating in problem-solving and CI projects. 
• Attend and actively participate in daily tier meetings. 

Minimum Qualifications 

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment. 
• Advanced knowledge of cGMP requirements, regulatory expectations, and quality systems, including deviations, CAPAs, audits, and inspections. 
• Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members. 
• Ability to effectively read, write, speak, and understand English to communicate complex technical information cross-functionally. 
• Exceptional attention to detail with proven ability to review and ensure accuracy of critical documentation and records. 
• Strong mathematical, analytical, and problem-solving skills, with the ability to interpret data, identify