Manufacturing Technician IV

The Level VI Production Operator (Technician IV) executes, runs autonomously, advises and leads complex activities of aseptic manufacturing of batches, 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. In addition, they must ensure the execution of production plans, following all company safety guidelines. A high level of detail is required due to the complexity of the activities to be performed. The minimum training time for this is normally 5 years.

Responsibilities

Executes, runs autonomously, advises and leads complex activities of aseptic manufacturing of batches, billable activities, or continuous improvement activities required in the production department; Ensures execution of production plans following all company safety guidelines; Complies with manufacturing area safety regulations and work practices; Works as a team, being approachable, practical, motivating, able to support and inspire co-workers; Complies with schedule following prioritization instructions of senior managers; Collaborates in identifying opportunities for continuous improvement; Complies with cGMP, AEMPS, FDA and other regulatory agency requirements; Collaborates in preparing for inspections by regulatory agencies or clients; Participates in control of stock of plant consumables; Collaborates in investigations of quality events; Informs direct manager of equipment anomalies or human errors; Informs direct manager if safety equipment or human resources needs are identified; Collaborates in teamwork with other departments; Takes care of and ensures proper functioning of equipment; Operates production equipment following work procedures; Participates in manufacture of different products following manufacturing guides and cGMP regulations; Handles pallet trucks for movement of goods; Reviews relevant SOPs and production lot records; Completes and maintains documentation related to assigned work; Maintains cleanliness and order of production areas; Supports manufacture of different products; Supports qualification of production equipment; Leads dispensing and preparation of materials; Performs sanitization of materials; Disinfects classified and non-classified clean production rooms; Leads set up activities grade D/C; Leads set up activities grade A/B; Leads formulation processes grade C; Leads formulation processes grade A/B; Leads filtration processes grade C; Leads filtration processes grade A/B; Leads filling activities; Leads SIP execution of sterilizable equipment; Leads SIP execution of complex sterilizable equipment; Trains technicians level III; Acts as shift supervisor back-up

Requirements

Minimum training time normally 5 years; High level of detail required; General knowledge of aseptic techniques; Successful participation in gowning qualification and media fill plan