Manufacturing Technician II (Level II Production Operator)

About the role

The Level II Production Operator (Technician II) runs autonomously the batch aseptic manufacturing activities, billable activities and continuous improvement tasks required in the production department, following instructions and standard operating procedures in line with AEMPS, FDA and other regulatory agencies, under supervision. The role demands a high level of detail because of the complexity of the activities, and typically requires about 3 years of training to develop fully.

Key responsibilities

• Operate production equipment according to work procedures and manufacturing guides, supporting the manufacture of products while complying with cGMP and quality standards.
• Prepare, dispense and sanitize materials; disinfect clean production rooms and lead set-up of Grade D/C processes (e.g. autoclave cycles, equipment cleaning).
• Lead Grade C formulation and filtration processes and support Grade A/B processes, as well as filling and sterilizable equipment activities.
• Take care of equipment, handle pallet trucks, and keep production areas clean and orderly.
• Complete batch records and other documentation, review SOPs and lot records, and report equipment anomalies, human errors and safety needs to the manager.
• Participate in quality event investigations, prepare for regulatory inspections and collaborate on continuous improvement.
• Train Level I technicians and demonstrate general knowledge of aseptic techniques, including gowning qualification and media fill participation.

Required profile

• Ability to work as a team, be approachable and practical, and motivate colleagues.
• Follows schedules and prioritisation instructions of senior managers and the department head.
• Complies with health, safety and environmental programmes and with cGMP, AEMPS and FDA requirements.
• Typically around 3 years of training experience.