Filling Set-up Sr. Technician, Operations (2nd Shift) - Onsite

This position will be responsible for hands-on processing activities that include sterile filling, lyophilization, and capping. Specific tasks include filling line set-up, executing machinability runs and performing simple adjustments to ensure that the GMP processing runs smoothly.

Key Responsibilities

• Provide hands-on troubleshooting and adjustment for process and production equipment to ensure safe, compliant and reliable manufacturing operations in a cGMP-regulated environment
• Work closely with Production, Quality, EHS and Engineering to drive continuous improvement to maximize reliability of manufacturing operations
• Work with complex, high speed automated systems with mechanical and digital interfaces
• Familiar with robotic positioning, understanding manual placement utilizing remote pendant to position axis
• Experience with vision systems
• Experience with PLC interfaces and multi-screen HMIs; experience with automation heavy environments
• Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)
• Perform aseptic interventions within a Grade A Isolator
• Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols
• Set up, change over, and test run equipment for various size containers, stopper, and caps as required
• Make mechanical and electrical adjustments necessary for the correct operation of the equipment
• Conduct routine microbial and particulate sampling for environmental monitoring
• Maintain accurate records of inspection results and findings in an electronic system
• Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations
• Report any recurring issues or trends to management for further investigation
• Gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
• Communicate clearly with team and work closely with other teams to ensure on time delivery
• Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards
• Identify and escalate issues, perform basic troubleshooting, and capture learnings to improve systems and processes
• Attend and actively participate in safety, quality, and process improvement initiatives
• Support investigations and implementation of corrective/preventative actions

Education Minimum Requirements

High School Diploma/GED or higher, or successful completion of an associates degree in Applied Science (A.A.S) or an equivalent associate degree program or vocational certificate in lieu of the degree program or equivalent military course work.

Preferred Education

Trade certificate, technical diploma, or Associate of Applied Science (A.A.S.) in Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or a related field.

Required Experience and Skills

• Minimum of 2 years experience as a technician in a manufacturing, military, automotive, aviation or industrial facility
• Experience including set-up changeover, assembly, disassembly, operation and modifications of complex, high speed equipment
• Demonstrated written and verbal communication skills
• Proficiency in computer systems and applications including Microsoft Office (Word, Excel and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems
• Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators
• Demonstrated ability to work and communicate both independently and as part of a team
• Flexibility working overtime is a requirement in manufacturing, especially during shutdowns or emergency repairs

Preferred Experience and Skills

• Experience in regulated manufacturing (pharmaceutical/biotech) under cGMP
• Experience in automotive or aerospace
• Experience with highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems
• Associates Degree in science or related field
• BioWork Certificate (working in an FDA or similar regulated industry)
• Experience with automated systems (MES, SAP, or similar)
• Demonstrated troubleshooting / problem-solving skills