Role Summary
Lead Process Technician or Senior Technical Specialist (3rd Shift) responsible for advanced troubleshooting, training, continuous improvement, and maintenance within a Lean manufacturing environment. Roles include optimizing packaging lines, driving root cause investigations, and ensuring compliance with GMP/SOP requirements.
Responsibilities
- Equipment Troubleshooting & Diagnostics: Specialize in troubleshooting for packaging equipment (mechanical and highly automated systems) and collaborate with operations, maintenance, and engineering to prioritize work, reduce downtime, and improve line reliability.
- Continuous Improvement: Proactively review equipment operation, identify deficiencies, and recommend improvements to increase OEE and support Lean initiatives through key projects.
- Technical Advisory: Provide input on parts/material selection, documentation (OJT and SOP creation), testing, problem solving, maintenance requirements, and project scope.
- Machine Changeovers: Provide technical support during changeovers for different package sizes and set up lines for smooth startups and increased efficiency.
- Root Cause Analysis: Initiate and participate in RCAs to address recurring issues and implement effective solutions.
- Training & Compliance: Provide training on equipment maintenance and operation, ensuring compliance with SOPs, GMPs, and other regulations.
Qualifications
- Senior Technical Specialist
- High school diploma or GED
- Basic math and reading comprehension
- Effective communication and leadership abilities
- Ability to follow detailed instructions
- Strong mechanical abilities; operate, maintain, troubleshoot, and perform minor repairs on production equipment
- Mechanical reasoning skills essential for troubleshooting
- Strong knowledge of GMPs and production practices
- Experience in Lean Manufacturing and continuous improvement (5S, visual schedule, M1, etc.)
- Ability to train on area SOPs/OJTs; experience creating/maintaining training documentation
- Lead Process Technician
- Trade certification or degree in engineering, automation, or related field strongly preferred
- 10+ years of experience in manufacturing/packaging, especially with highly automated pharmaceutical equipment
- Strong mechanical aptitude and advanced troubleshooting
- Familiarity with Lean Manufacturing principles
- Understanding of safety, compliance, and regulatory standards in pharmaceutical operations
- Effective communication and team collaboration
- Ability to stand, walk, bend, and lift for extended periods
- Comfortable in a fast-paced, production-driven environment
- Production Floor presence and support for assigned shift
- Able to perform other duties as required
Skills
- Lean Manufacturing and continuous improvement
- GMPs, SOPs, and regulatory compliance
- Advanced troubleshooting of mechanical and automated packaging equipment
- Root cause analysis and problem-solving tools
- Training and documentation development
Education
- High school diploma or GED (Senior Technical Specialist)
- Trade certification or degree in engineering/automation (Lead Process Technician, preferred)