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Job Description POCS Rahway: Technician Operations (FLEx Sterile Filling Technician) Level: O3 Job Family: Manuf/Operations 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 Filling. This position will be responsible for hands-on processing activities that include sterile filling and lyophilization and capping. There will be opportunity for technicians to cross-train in other parts of the process including thaw formulation visual inspection and sterile supply. 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. Key Responsibilities: * Aseptic Processing: Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Experience with operating isolator filling machines is required. * Aseptic experience: Experience in working in Grade A environment is required including aseptic qualification and performing environmental monitoring. * Isolator Operation: Operate and maintain large complex isolators ensuring optimal performance and adherence to safety protocols. * Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system. Knowledge of PAS-X is preferable. * GMP: Follow established inspection batch records protocols and quality standards to ensure compliance with industry regulations. Able to report any recurring issues or trends to management for further investigation. * Cleanroom Environment: Able to gown and work in Grade C conditions maintaining good aseptic cleanroom behaviors * Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery. * Training and Compliance: Assist in training new staff on sterile supply procedures and protocols ensuring adherence to GMP standards. * Leadership: Able to identify and escalate issues perform 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 actively participates in safety quality and process improvement initiatives to enhance flexibility efficiency and compliance. * 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 at least 5 years in pharmaceutical manufacturing or processing * OR Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing * OR Bachelors Degree in Engineering Technology or related field Required Experience and Skills: * Relevant GMP Pharmaceutical experience or equivalent (e.g. chemical nuclear military experience). * Demonstrated written and verbal communication skills. * Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word Excel and Outlook) Equipment HMI use MODA PAS-X SAP Calibration/Maintenance Database Systems. * Must be willing and able to lift 50 lbs bend stoop squat crawl twist climb ladders and don & wear cleanroom protective gowning including respirators. * Supports investigations and implementation of corrective/preventative actions. * Flexibility working overtime is a requirement in manufacturing * Supports investigations and implementation of corrective/preventative actions. Preferred Experience and Skills: * Familiarity with regulatory requirements and Good Documentation Practices (GDP). * Experience with some of the following: highly complex and state of the art equipment isolators containment technology aseptic filling using automated machinery sterile manufacturing SAP or other ERP systems. * Associates Degree in science or related field. * BioWork Certificate (working in an FDA or similar regulated industry). * Experience with automated systems (MES SAP or similar). * Demonstrated troubleshooting / problem-solving skills. * Demonstrated ability to identify and initiate process improvements. First and second shift openings available #MSJR #eligibleforERP #PSCS Required Skills: Biopharmaceutical Manufacturing CNC Operations Computer Literacy Data Analysis FDA Regulations Good Manufacturing Practices (GMP) Laboratory Techniques Manufacturing Quality Control Master Batch Records Material Selection Pharmaceutical Process Development Production Planning Regulatory Compliance Shift Work Teamwork Preferred Skills: Current Employees apply ___

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