Lead Production Technician

Polymer Technology Systems, Inc•Whitestown, IN

25d

About The Position

The Lead Production Technician performs duties across operations to produce PTS products, applying progressive manufacturing skills and knowledge. The role documents manufacturing processes and monitors production to ensure product safety, quality, efficiency, and conformance to specifications. The Lead Production Technician ensures Quality System Work Instructions are accurate and that crew members are trained to follow them. The position provides hands-on production leadership, including setting up and operating manufacturing equipment, training employees, overseeing inspections and equipment maintenance, monitoring production metrics, and coordinating responses to production issues. It supports production schedules and goals while maintaining accurate records and complying with applicable quality-system and regulatory requirements. The role requires flexibility to work irregular or extended hours as needed. Production work takes place in controlled-temperature and humidity rooms, where task-specific personal protective equipment is required. The employee must follow quality and regulatory requirements and report potential compliance concerns to managers and the Head of Quality.

Requirements

High school diploma or GED.
One to two years of related manufacturing experience in the medical device, pharmaceutical, or biotech industry, or an equivalent combination of education and experience.
Experience managing or leading a team.
Understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
Ability to lift approximately 25 pounds.
Ability to work varied, irregular, and extended hours as required.
Ability to communicate clearly and effectively with peers, supervisors, and managers.
Effective verbal and written communication skills.
Strong attention to detail.
Basic computer skills, including the ability to type emails, QT9 items, work-instruction updates, and other materials as needed.
Ability to solve basic math problems.
Ability to learn, train, and teach employees.
Ability to stand and/or sit for extended periods, reach with hands and arms, and repeatedly touch, manipulate, handle, or feel production items or materials.
Close-vision ability.

Nice To Haves

Experience in an FDA-regulated environment.

Responsibilities

Ensure the production area is safe and has the inventories and tools needed to keep production running.
Complete assigned daily tasks to meet production volume, quality, and schedule requirements.
Prepare and assemble products according to established work instructions and company procedures.
Set up and operate manufacturing equipment and work centers, and train others to use them.
Manage setup, operation, and training for multiple complex manufacturing equipment in coordination with the Supervisor and Tech III.
Inspect finished products and incoming materials for quality and conformance to PTS specifications.
Work primarily in the assigned department and in other departments as directed by the supervisor.
Prepare and verify materials issued to work orders.
Contribute to production goals, equipment yield, and efficiency targets to meet the production schedule.
Understand process flow across production steps, identify opportunities to improve efficiency, and train technicians on process flow.
Troubleshoot equipment and workstations and escalate issues to maintenance or a Tier III Technician when appropriate.
Monitor production metrics and take action when issues arise.
Complete accurate production paperwork, including times, quantities, forms, work orders, batch records, and reports.
Communicate downtime problems and issues effectively with Maintenance, Manufacturing Engineering, and Management.
Monitor departmental machines and manage resolution of problems.
Oversee in-process inspections of components and assemblies for quality conformance.
Oversee cleaning and maintenance of equipment and work areas as needed.
Recognize minor equipment or documentation issues and take appropriate corrective action within scope.
Provide ongoing leadership in a team environment and train and teach employees.
Report causes of process or documentation issues and assist with or coordinate resolutions.
Lead shift changes, lot changes, and production start-ups.
Comply with applicable quality-system and regulatory requirements, maintain a quality-focused approach, and report potential compliance concerns to managers and the Head of Quality.
Perform other duties as assigned by the Supervisor, Senior Supervisor, Production Manager, or supervisor.