Lead Manufacturing Technician (Nights)

Role Summary

Lead Manufacturing Technician oversees and executes production processes in a cGMP environment. Location: USA - IL - Round Lake. Under general supervision, manages the hands-on execution of all activities in the production area, revises or initiates procedures as needed, and supports the transfer of new technologies into manufacturing. Demonstrates leadership in cGMP compliance and safety, coordinating with maintenance, quality, and other teams.

Responsibilities

• Lead training efforts and mentoring for manufacturing technician progression from level 1-3
• Conduct safety Gemba observations and provide coaching daily to ensure technicians follow 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 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

• 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

Education

• High school diploma or GED

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body; may include additional hearing protection for loud areas
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment
• Work in a cold, wet environment
• Work multiple shifts, including weekends, or be asked to work supplemental hours; may include 24/7 operations
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
• Will work on multiple shifts, including weekends and holidays, to support a 24/7 manufacturing operation
• Will work a 12-hour shift (5:00 PM – 5:30 AM), in a 2-2-3 rotation (C Shift)
• Will work non-traditional work hours, including weekends and holidays and overtime
• May require immunization before performing work within the manufacturing area