Manufacturing Technician IV
hace 5 días
León
ppLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. /p pWe are PCI. /p pOur 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. /p pThe 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. /p ul liComply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs. /li liWork as a team, being approachable, practical, motivating, able to support and inspire your co-workers. /li liComply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head. /li liCollaborate in the identification of opportunities for continuous improvement to improve processes and practices. /li liComply 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. /li liCollaborate and participate in preparing for inspections by regulatory agencies or clients. /li liParticipate in the control of the stock of plant consumables, to guarantee their availability. /li liCollaborate in the investigations of the different quality events (deviations, capas, change controls). /li liInform 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. /li liInform the direct manager if safety equipment or human resources needs are identified. /li liCollaborate in teamwork with other departments if required. /li liTake care of and ensure the proper functioning of the equipment. /li liOperate production equipment following the guidelines indicated in the work procedures. /li liParticipate in the manufacture of the different products following the indications of the manufacturing guides and complying with cGMP regulations. /li liHandle pallet trucks for the movement of goods. /li liReview relevant SOPs and production lot records, as needed. /li liComplete and maintain documentation related to assigned work, including notebooks, batch records, etc. /li liComply with and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures. /li liSupports the manufacture of the different products following the instructions of the manufacturing guides and complying with cGMP regulations. /li liSupports the activities of the qualification of production equipment. /li liDemonstrate a general knowledge of aseptic techniques (maintaining difficult body posture and movement during long periods of time). /li liSuccessful participation in the gowning qualification as well as the media fill plan. /li liLeads the activities of dispensing and preparing materials to be used in the activities of the department. /li liPerform the sanitization of materials prior to their introduction into the manufacturing areas. /li liDisinfect classified and non‑classifies clean production rooms. /li liLeads the activities of set up grade D/C (ex. activities of the processes of preparation of autoclave cycles and assembly of installations, performing cleaning of production equipment). /li liLeads the activities of set up grade A/B. /li liLeads the activities of formulation processes grade C. /li liLeads the activities of formulation processes grade A/B. /li liLeads the activities of filtration processes grade C. /li liLeads the activities of filtration processes grade AB. /li liLeads filling activities. /li liLeads the activities of sip execution of sterilizable equipment. /li liLeads the activities of sip execution of complex sterilizable equipment. /li liTrains technicians level III. /li liShift supervisor back‑up. /li /ul pJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future. /p h3Equal Employment Opportunity (EEO) Statement /h3 pPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. /p pAt PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. /p /p #J-18808-Ljbffr
