Please note that this is a 1 year contract position.
Our client is seeking a Manufacturing Technician 2 to work as part of their RhoGAM team. You will be responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to formulation, filtration, purification, reagent preparation, processing of plasma by protein fractionation, Viresolve and Viral Inactivation processes according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. You will also ensure materials are available to meet production schedule. And, you will be responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.
This position is located in Raritan, NJ. This is a 1st shift position (4:00 am to 12:00 pm) that will be extended every other week and with abbreviated Sundays and overtime as needed.
• Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
• Support schedule adjustments to meet production, material receipt and shipping requirements and review schedule.
• Perform and understand detailed processes to include: filtration, reagent preparations, fractionation, Viresolve and viral inactivation.
• Perform in-process testing as required by processes and procedures utilizing instrumentation, such as: (pH meters, conductivity bridge, scales, columns and pumps) list is not all inclusive.
• Knowledge and understanding of test methods and interpretation of results.
• Verify and enter production parameters per SOP and Batch Records.
• Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
• Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.
• Clean, prepare and assemble equipment for processing operations including stationary tanks, filter housings, collection vessels, centrifuges and mixing apparatus.
• Operate and troubleshoot equipment in clean room and non-clean room environment.
• Monitor environmental conditions inside and outside classified rooms.
• Use of ERP system for performing material transactions/moves/quantities/cycle counts.
• Demonstrate training progression through assigned curriculum
• Knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
• Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Perform other work-related duties as assigned.
• Bachelor’s Degree in Science, Biology or a related field of study is desirable.
• Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience is required.
• Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment is required.
• Prior work in a cGMP area and/or clean room environment is required.
• Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment.
• Performs and has good understanding of processes and procedures.
• Assist or may lead troubleshooting of routine manufacturing equipment and processes and notifies supervision of any issues.
• Demonstrate a good understanding of the process in order to properly perform the assigned manufacturing tasks.
• Identifies discrepancies or trends that might need additional attention and notifies supervision
• Ability to lift up to 40 lbs.
• Work with blood, blood products and chemicals.
• Overtime is required, as necessary.
Applicants must provide their phone number. Reference job number A1953.