That may include fabrication and systematic modifications.
Maintains an effective management process for parts, equipment, and tools.
Compliance & Documentation
Ensures strict adherence to Standard Operating Procedures (SOPs) and cGMP.
Reviews Batch Production Records (BPR), Preventative Maintenance logs, track activities in CMMS, and complete necessary documentation for compliance and regulatory requirements.
Responsible for the record keeping of maintenance repairs performed.
Training & Mentorship
Mentors’ junior technicians on aseptic techniques, equipment operation, and proper gowning procedures by working on floor side by side with maintenance staff.
Continuous Improvement
Identifies opportunities for process improvements, such as reducing scrap, increasing efficiency, and implementing 5S. Effectively reducing downtime and maintaining a continuous production schedule.
Safety Enforcement
Enforces safety rules, including Lockout/Tagout (LOTO), PPE usage, and hazardous material handling.
Implements and enforces safe work practices.
Technical Expertise
Possesses strong mechanical skills for troubleshooting complex, automated machinery.
Solves problems related to gears, levers, pulleys, and PLCs, including troubleshooting sensors, switches, and control outputs of motors and solenoids.
Aseptic Knowledge
Deep understanding of aseptic behaviors, media fills, and sterile gowning qualifications, following the guidelines and requirements of ISO 22716.
GMP & Regulatory Adherence
Familiar with ISO 9001, ISO 22716, and other safety regulations.
Leadership & Communication
Able to manage team performance, coach for development, and communicate effectively across departments such as Quality, Maintenance, and Production.
Maintain team attendance and shift schedule
Address team performance issues with Manager.
Other duties as assigned.
Education & Experience
Experience
3+ years of supervisory experience required.
5 + years of related experience in a regulated manufacturing environment.
Experience performing maintenance on mechanical equipment, hydraulics, pneumatics, and industrial electricity required.
Education
High School diploma required.
An associate degree in a technical field or equivalent experience.
ISA Certified Control Systems Technician (CCST-III), NICET Certification, NC3, and like certifications strongly preferred.
System Proficiency
Familiarity with ERP systems (e.g., SAP, LIMBLE) and Microsoft Office (Excel, PowerPoint, Outlook, Teams).
Physical Requirements
Ability to work in a sterile or controlled environment, including wearing hair and beard nets.
Ability to lift 10 to 20 lbs. of force constantly, 25 to 50 lbs. of force frequently and 50 to 100 lbs. of force occasionally.
Flexibility to work extended shifts and or weekends as needed to meet production demands.
Skills & Abilities
Ability to operate machines, hand tools and electronic equipment.
Ability to troubleshoot electrical and mechanical problems.
Ability to assemble and disassemble equipment.
Excellent project management and planning skills required.
Ability to display leadership skills.
Strong management and communication skills required.
Bilingual (English/Spanish) required.