Technical Operations Scientist

The Senior Scientist is responsible for giving continuous support to the following validation programs: Production Equipment (moist heat / depyrogenation), Filter Qualification, Cleaning validation, Processes validation, Qualifications, and Aseptic Process Simulation (APS). The incumbent is also responsible for the feasibility, assessment and execution of the different project steps and coordinating activities with the different units of the Janssen Cilag Manufacturing, LLC organization, as the need arises. This position enables the company to be aligned with the current regulatory requirements of the pharmaceutical industry. II. CATEGORY Exempt III. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES Lead and execute process, cleaning, sterilization process, machine-abilities, lyophilization cycle validations and APS studies. Search for literature to understand the systems, equipment and processes presently used in our GMP related operations. Develop validation protocols based on available literature, company procedures, guidelines, and applicable regulations. Coordinate with other departments and execute all the activities vital for the validation program. Compile, review and analyze validation data and summarizes results and conclusions in technical reports. Preparation of Technical Reports (RPT’s) to document technical activities in support of regulatory compliance and submissions. Design of studies and preparation of protocols to evaluate alternate components and raw materials, alternate methods of manufacture, process and product anomalies, cost savings opportunities, and process, equipment, and cleaning validation. Provide technical support to investigations and resolution of process deviations. Initiate Change Controls and complete technical / validation assessments to changes owned by other functional groups. Provide technical expertise on procedures and Validation Master Plan revisions. Provides technical training in technical areas such as: qualification, validation, technical transfer, and new process implementation. Special Project execution / coordination. Participate and provide technical expertise in the critical review of all document associate with the manufacturing of sterile products. Lead aseptic processing special projects to accomplish company goals and objective on the timely and effective manner. Collaborate directly with manufacturing operations to ensure that appropriate environmental and aseptic procedures are in place, through the execution of comprehensive reviews of procedures against practice. Work with other teams to address technical issues and resolve them using sound scientific reasoning and technical expertise. Provides guidance to the team on technical issues. Identify areas of process improvements. Works with technical groups to implement process improvements. May lead process improvements initiatives depending on complexity. Participate in audits. Supports regulatory agency interactions. Qualifications This position requires bachelor’s degree in Chemistry, Pharmacy, Biochemist, Chemical Engineering or related Science or Engineering. Desire a master’s degree in Science or Engineering. Knowledge of cGMP's, FDA regulations, MCA & Japan regulations, Aseptic techniques, lyophilization technology, pharmaceutical manufacturing equipment, utilities and environmental controlled areas and process and cleaning validation is required. The incumbent must have 10+ years’ experience in Parenteral Industry. Must have vast knowledge of lyophilization process and aseptic manufacturing process. Experience in a Technical support or Manufacturing environment in the pharmaceutical / medical device or similar industry required. Broad Knowledge on Technical support writing, communication skills, computer literature, collaboration is required Able to travel outside of P.R. when required. Able to work under time pressure, confirmed leadership skills. Able to work in a manufacturing environment of Parenterals products. Primary Location United States-Puerto Rico-Gurabo- Organization Janssen - Cilag Mfg LLC (8427) Job Function R&D Requisition ID 2206014293W