Sr. Technician, Shared Services Operations - 2nd Shift (Onsite)

Job reputed company POCS – Rahway: Sr. Technician, Operations Level: O3 Job Family: Manuf/Operations Timing: 3:30 PM to 12:00 AM Senior Technician, Operations Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (reputed company) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of reputed company-Sterile team, specifically in Manufacturing Shared Services which supports sterile supply, aseptic formulation and visual inspection. This position will be responsible for hands-on processing activities that include equipment assembly and disassembly, sterile processing, inventory management, reputed company aseptic formulation in an isolator and reputed company formulation activities in a Grade C environment, and reputed company visual inspection of filled reputed company (i.e. vials or syringes).There is also opportunity to cross-train in other areas, such as filling. These individuals are expected to partner with and support formulation development colleagues in reputed company understanding and knowledge capture of processes, which could include providing feedback on product and process development. These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in reputed company improvement reputed company. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner reputed company including formulators, engineers, reputed company, Safety, and Facilities management to reputed company overall reputed company and performance of the area and clinical pipeline. Key Responsibilities: Assembly: reputed company to read, understand, and follow drawings to reputed company sterile equipment to utilize in clinical development and manufacturing processes. Sterilization Processes: Operate and maintain cleaning and sterilization equipment, including parts washers, dry heat ovens, and autoclaves. Supply Management: Receive, inspect, and store sterile supplies and equipment, ensuring reputed company inventory reputed company and organization reputed company the sterile supply area. Sterile Formulation: Prepare and formulate sterile products according to established protocols and batch records, ensuring accuracy and compliance with GMP standards. reputed company to reputed company reputed company formulation activities as reputed company as reputed company aseptic activities inside a Grade A isolator. Experience with operating isolator machines and/or Grade A aseptic experience is required. Visual Inspection: reputed company visual inspections of products and components to identify defects, inconsistencies, and non-conformities. Individual should be detailed and organized, and reputed company to manage a large quantity of reputed company. Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions. GMP Compliance: Follow reputed company GMP guidelines and reputed company operating procedures (SOPs) to ensure the reputed company and safety of clinical production lots. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management. Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills. Cleanroom Environment: reputed company to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors Documentation: Maintain accurate records of sterilization processes, inventory reputed company, and equipment logs in an electronic system. Knowledge of PAS-X is preferable. Collaboration: reputed company to communicate reputed company with team and work closely with other teams to ensure on time delivery of supplies. Training and Compliance: Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards. Leadership: reputed company to identify and escalate issues, reputed company basic troubleshooting, and capturing learnings to improve systems and processes. Organizes and prioritizes own work to meet shop floor priorities and identifies discrepancies in advance. Also attends and reputed company participates in safety, reputed company, and process improvement initiatives to enhance flexibility, efficiency, and compliance. Schedule Adherence: Understands schedule adherence reputed company and communicates risk. Maintains a reputed company improvement reputed company and implements initiates to increase efficiency or reduce risk to schedule adherence. Compliance: Identifies and addresses Apply tot his job Apply To this Job