Manufacturing Technician IV (Level VI Production Operator)

About the role

PCI Services is hiring a Manufacturing Technician IV (Level VI Production Operator) in its production department in Leon. This role executes, runs autonomously, advises and leads complex activities of aseptic manufacturing of batches, billable activities or continuous improvement projects, following instructions and standard operating procedures in line with AEMPS, FDA and other regulatory agencies, while ensuring production plans are carried out according to company safety guidelines. A minimum training period of about 5 years is normally required.

Key responsibilities

• Operate production equipment and lead formulation, filtration, sterilization and filling processes (grades A, B, C, D) in aseptic clean rooms, including set-up and grade D/C activities.
• Prepare, sanitize and dispense materials, disinfect clean rooms and support equipment qualification.
• Produce products according to manufacturing guides and cGMP, and keep batch records, notebooks and other documentation complete and accurate.
• Take care of equipment, handle pallet trucks, control stock of plant consumables and help prepare for regulatory or client inspections.
• Investigate quality events such as deviations, CAPAs and change controls, and report anomalies, safety needs and human errors to the direct manager.
• Work as a team, follow schedules and priorities, and train Level III technicians; act as shift supervisor backup.

Required profile

• Minimum training of about 5 years.
• Knowledge of aseptic techniques and successful participation in gowning qualification and media fill plan.
• Ability to maintain good posture and movement during long periods in difficult positions.
• Team player who supports and inspires colleagues and complies with health, safety and environmental programmes.