Manufacturing Technician II
On-siteLeon, Galicia, Kingdom of Spain
Job Summary
Execute batch aseptic manufacturing, continuous improvement, and billable activities autonomously while adhering to AEMPS, FDA, and cGMP regulations. Operate production equipment, lead formulation processes for grades A/B/C, and manage filtration and filling operations. Prepare materials, sanitize equipment, and disinfect clean production rooms. Collaborate on quality investigations, prepare for regulatory inspections, and maintain stock of plant consumables. Train Level I technicians and ensure proper documentation of all assigned work. Maintain cleanliness and order in production areas. Comply with safety protocols and inform managers of equipment anomalies or resource needs. Work as a team to support department objectives and prioritize schedules.
Required Qualifications
- Demonstrate a general knowledge of aseptic techniques
- Successful participation in the gowning qualification as well as the media fill plan
- Handle pallet trucks for the movement of goods
- Review relevant sops and production lot records, as needed
- Complete and maintain documentation related to assigned work, including notebooks, batch records, etc
- Comply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs
- Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies that have been implemented in the plant, as well as with the department's objectives and corporate quality standards
- Take care of and ensure the proper functioning of the equipment
- Operate production equipment following the guidelines indicated in the work procedures
- Participate in the manufacture of the different products following the indications of the manufacturing guides and complying with cGMP regulations
- Perform the sanitization of materials prior to their introduction into the manufacturing areas
- Disinfect classified and non classifies clean production rooms
- Leads the activities of set up grade D/C
- Leads the activities of formulation processes grade C
- Leads the activities of filtration processes grade C
- Supports filling activities
- Supports the activities of sip execution of sterilizable equipment
- Trains Technicians level I
- Comply with and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.