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

Responsibilities

• Assembly: Able to read, understand, and follow drawings to assemble 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 proper inventory levels and organization within the sterile supply area.
• Visual Inspection: Perform visual inspections of products and components to identify defects, inconsistencies, and non-conformities. Individual should be detailed and organized, and able to manage a large quantity of units.
• Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.
• GMP Compliance: Follow all GMP guidelines and standard operating procedures (SOPs) to ensure the quality 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: Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
• Documentation: Maintain accurate records of sterilization processes, inventory levels, and equipment logs in an electronic system. Knowledge of PAS-X is preferable.
• Collaboration: Able to communicate clearly 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.
• Schedule Adherence: Understands schedule adherence impact and communicates risk. Maintains a continuous improvement mindset and implements initiates to increase efficiency or reduce risk to schedule adherence.
• Compliance: Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management. Able to redline SOPS for continuous improvement.
• Supports investigations and implementation of corrective/preventative actions.
• Positions are based in Rahway, NJ and 100% on-site.
• Education Minimum Requirements :
• High School Diploma/GED, with

Additional Information

Job Description 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 (FLEx) 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 the FLEx-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, open aseptic formulation in an isolator and closed formulation activities in a Grade C environment, and manual visual inspection of filled units (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 further 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 continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.

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