Manufacturing Technician II Job at PCI Pharma Services (Leon)

Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. 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. Join us and be part of building the bridge between life changing therapies and patients.

Job Responsibility

The Level II Production Operator (Technician II) executes and runs autonomously the batch aseptic manufacturing activities, billable activities, or continuous improvement activities required in the production department, following instructions and standard operating procedures in accordance with the AEMPS, FDA, and other regulatory agencies under supervision
Ensure the execution of production plans, following all company safety guidelines

Requirements

Comply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs
Work as a team, being approachable, practical, motivating, able to support and inspire your co-workers
Comply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head
Collaborate in the identification of opportunities for continuous improvement to improve processes and practices
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
Collaborate and participate in preparing for inspections by regulatory agencies or clients
Participate in the control of the stock of plant consumables, to guarantee their availability
Collaborate in the investigations of the different quality events (deviations, capas, change controls...)
Inform the direct manager when anomalies are detected in the operation of equipment, as well as human errors, both their own and those of the team's personnel, to ensure the quality of the product manufactured
Inform the direct manager if safety equipment or human resources needs are identified
Collaborate in teamwork with other departments if required
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
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 and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures
Operate production equipment following the guidelines indicated in the work procedures
Supports the manufacture of the different products following the instructions of the manufacturing guides and complying with cGMP regulations
Supports the activities of the qualification of production equipments
Demonstrate a general knowledge of aseptic techniques (maintaining difficult body posture and movement during long periods of time)
Successful participation in the gowning qualification as well as the media fill plan
Leads the activities of dispensing and preparing materials to be used in the activities of the department
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 ( ex. activities of the processes of preparation of autoclave cycles and assembly of installations, perform cleaning of production equipment…)
Supports the activities of set up grade A/B
Leads the activities of formulation processes grade C
Supports the activities of formulation processes grade A/B
Leads the activities of filtration processes grade C
Supports the activities of filtration processes grade AB
Supports filling activities
Supports the activities of sip execution of sterilizable equipment
Trains Technicians level I

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Manufacturing Technician II

Job Description

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