Lead Manufacturing Technician (Nights)

Role Summary

Lead Manufacturing Technician (Nights) responsible for executing all production processes in a cGMP environment under supervisor direction. Manages hands-on activities in the production area, revises and may rewrite procedures, troubleshoots complex issues, and may assist in transferring new technologies into manufacturing. Demonstrates leadership in cGMP compliance and safety.

Responsibilities

• Lead training efforts and mentoring for manufacturing tech progression from level 1-3
• Conduct safety Gemba's and provide coaching daily to ensure technicians are following proper ergonomic techniques
• Support all local manufacturing operations
• Demonstrate proficiency in electronic systems such as (EBM, JDE, etc.)
• Operate general production equipment (such as Filling, Inspection & Packaging equipment)
• Ensure relevant paperwork following GDP/GMP guidelines
• Manually clean all portable equipment and small parts
• Participate on Continuous Improvement Teams
• Receive and distribute supplies into the production area
• Monitor daily cleaning of the production area to maintain in GMP fashion. Assemble and operate filtration systems
• Ensure all components necessary for Manufacturing are prepped and ready to meet schedule adherence in addition to setting up incoming shift for success
• Troubleshoot process & equipment problems promptly to minimize Manufacturing downtime
• Coordinate with other groups such as maintenance/metrology to ensure preventative maintenance is done per plan

Qualifications

• High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience
• Will speak, read, write, and follow detailed written and oral instructions in English
• Must have excellent written and verbal communication skills and understanding of cGMP regulations
• Procedural writing skills, required
• Experience with pharmaceutical production equipment including autoclave
• Will apply quantitative analysis to analyze process performance
• You must be proficient in different mathematical disciplines and be able to work with both the metric and USA standards of measurement
• Highly effective interpersonal skills and be able to work in a team environment
• Knowledgeable of chemical and biological safety procedures
• Good computer skills

Skills

• Leadership and training
• cGMP and GDP/GMP proficiency
• Troubleshooting and problem-solving
• Documentation and procedural writing
• Office and production software familiarity
• Safety and ergonomic coaching

Education

• High school diploma or GED; additional AA or higher degree with related experience is acceptable

Additional Requirements

• Work in controlled environment with gowning and protective clothing; may require respiratory protection
• Cold, wet environment; potential for 12-hour night shifts (2-2-3 rotation) and weekends/holidays
• Immunization may be required for manufacturing work