Manufacturing Operator (Manufacturing Tech. I)
hace 17 horas
León
ppLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. /ppWe are PCI. /ppOur 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. /ppThe Level I Production Operator (Technician I) learns and executes the aseptic batch manufacturing activities, billable activities or continuous improvement that are required in the production department, following the instructions and standard operating procedures in accordance with the AEMPS, FDA and other regulatory agencies under supervision. Ensuring the execution of production plans, while following all the company's safety guidelines. /pulliComply with manufacturing area safety regulations and work practices in accordance with all company Health, Safety and Environmental programs. /liliWork as a team, being approachable, practical, motivating, able to support and inspire your co-workers. /liliParticipation in the "Quarterly conversation" /liliComply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head. /liliCollaborate in the identification of opportunities for continuous improvement to improve processes and practices. /liliComply 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. /liliCollaborate and participate in preparing for inspections by regulatory agencies or clients. /liliParticipate in the control of the stock of plant consumables, to guarantee their availability. /liliCollaborate in the investigations of the different quality events (deviations, CAPAs, change controls...). /liliInform 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, in order to ensure the quality of the product manufactured. /liliInform the direct manager if safety equipment or human resources needs are identified. /liliCollaborate in teamwork with other departments if required. /liliTake care of and ensure the proper functioning of the equipment /liliOperate production equipment following the guidelines indicated in the work procedures /liliParticipate in the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations. /liliHandle pallet trucks for the movement of goods. /liliDemonstrate a general knowledge of aseptic techniques /liliSuccessful participation in the gowning qualification as well as the Media Fill plan /liliReview relevant SOPs and production lot records, as needed. /liliComplete and maintain documentation related to assigned work, including notebooks, batch records, etc /liliComply with and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures. /liliPerform the activities of dispensing and preparing materials to be used in the activities of the department. /liliPerform the sanitization of materials prior to their introduction into the manufacturing areas /liliDisinfect and clean production rooms /liliSupports the activities of formulation processes /liliSupports the activities of the activities of filtration processes /liliSupports the activities of the processes of preparation of autoclave cycles and assembly of installations /liliSupports the activities of the qualification of Production equipments. /liliOperate production equipment following the guidelines indicated in the work procedures /liliPerform cleaning of production equipment /liliSupports the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations. /liliSupports the activities of SIP execution of sterilizable equipment /li /ulh3Equal Employment Opportunity (EEO) Statement /h3pPCI 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. /ppAt 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
