Manufacturing Technician IV in León

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Manufacturing Technician Level IV autonomously executes and leads complex activities involving aseptic manufacturing, preparation, formulation, filtration, filling, and equipment sterilization, as well as continuous improvement activities within the Production area.

Works in accordance with established procedures and in compliance with cGMP, AEMPS, FDA, and other regulatory authority requirements, guaranteeing the quality, safety, and compliance of production plans.

The position requires a high level of technical knowledge, autonomy, attention to detail, and leadership capacity, normally acquired after a minimum training period of approximately five years.

• Execute and lead aseptic manufacturing activities in Grade A/B, C, and D, including preparation and assembly, formulation, filtration, filling, sanitization, and disinfection.
• Lead SIP activities, including complex sterilizable equipment and systems, as well as support equipment and process qualification.
• Operate and ensure the correct functioning of production equipment, following SOPs, manufacturing guides, and GMP requirements.
• Guarantee compliance with safety, quality, GMP standards, and applicable regulatory requirements.
• Correctly manage and maintain GMP documentation, including batch records, logbooks, and associated records.
• Participate in investigations of deviations, CAPAs, change controls, and other quality events, as well as in regulatory and customer inspections.
• Identify and promote continuous improvement opportunities and collaborate with other departments when necessary.
• Manage the preparation and availability of materials and consumables necessary for production.
• Maintain cleaning, order, and control standards for classified and non-classified production areas.
• Maintain required qualifications, including gowning and Media Fill, and correctly apply aseptic techniques.
• Provide training and technical support to Level III Technicians.
• Act as backup for the Shift Supervisor, assuming delegated responsibilities when necessary.
• Work in a team, providing support, guidance, and technical leadership to other members of the area.