Manufacturing Operator (Manufacturing Tech. I) (León)

ppLife changing therapies. General impact. Bridge to thousands of biopharma companies and their patients. /ph3The Level I Production Operator (Technician I) /h3ulliLearn and execute aseptic batch manufacturing activities, billable activities, or continuous improvement activities required in the production department following instructions and standard operating procedures in accordance with AEMPS, FDA, and other regulatory agencies under supervision. /liliEnsure execution of production plans while following the company's safety guidelines. /liliComply with manufacturing area safety regulations and work practices in accordance with all company Health, Safety and Environmental programs. /liliWork as a team: be approachable, practical, motivating, able to support and inspire co‑workers. /liliParticipate in the “Quarterly conversation.” /liliComply with the schedule by following the prioritization instructions of senior managers to ensure compliance with 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 availability. /liliCollaborate in 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 personal and of the team—ensuring product quality. /liliInform the direct manager if safety equipment or human resource needs are identified. /liliCollaborate in teamwork with other departments if required. /liliTake care of and ensure proper functioning of the equipment. /liliOperate production equipment following the guidelines indicated in the work procedures. /liliParticipate in the manufacture of different products following the indications of the Manufacturing Guides and complying with GMP regulations. /liliHandle pallet trucks for the movement of goods. /liliDemonstrate general knowledge of aseptic techniques. /liliSuccessfully participate in 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 according to appropriate standard operating procedures. /liliPerform dispensing and preparation of materials used in the department activities. /liliPerform sanitization of materials prior to their introduction into manufacturing areas. /liliDisinfect and clean production rooms. /liliSupport activities of formulation processes. /liliSupport activities of filtration processes. /liliSupport activities of preparation of autoclave cycles and assembly of installations. /liliSupport activities of qualification of production equipment. /liliPerform cleaning of production equipment. /liliSupport manufacture of different products following the indications of the Manufacturing Guides and complying with GMP regulations. /liliSupport activities of SIP execution of sterilizable equipment. /li /ulpEqual Employment Opportunity (EEO) Statement: PCI 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. /p /p