Fill/Finish Associate (Internal Fill/Finish MFG)

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We are currently looking to fill a Fill/Finish Associate. The Fill/Finish Associate performs all duties related to the production and support of drug product manufacturing. Works individually, and as part of a team, to support and perform operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for parenteral biological products. Seeks to understand and develops proficiency in processes or procedures of increasing complexity. As a Fill/Finish Associate, a typical day might include the following: Produces life-saving therapeutics for various indications developed from a dynamic internal pipeline Works with a team that is accountable for production activities ranging from formulation of drug product to packaging of final drug product, which may include the following process-related responsibilities: Operates highly automated equipment to fill drug product into vials or syringes within isolators or other aseptic environments Assembles filled drug product into syringes and autoinjectors Operates state of the art packaging lines to place assembled and labeled drug product into packaging configurations for distribution Monitors production line for proper operation through process controls including pneumatics, robotics, manual and PLC feedback loop systems Cleans, handles, and installs interchangeable parts for various systems and equipment Collaborates to create and maintain operating procedures to perform routine activities that adhere to regulatory expectations Ensures working spaces and equipment are clean, safe, and ready for processing activities Maintains gowning qualification and adheres to clean room behaviors wherever required Performs environmental sampling using various methods where applicable Records GMP data that is accurate, legible, attributable, and contemporaneous and completes review on those records Maintains and ensures proper documentation of all training Navigates and utilizes electronic systems to support manufacturing operations Travel (domestic and international) may be required. Ensures compliance with applicable procedures while executing activities and escalates any non-conformities during operations Performs reconciliation of product and controlled materials where applicable This role might be for you if: Ability to perform basic algebra and geometry Reading/writing skills Must be able to stand for extended periods of time and lift, push and pull at least 50lbs. Knowledge of cGMP and FDA regulated (preferred) manufacturing environment and familiarity with cGMP filling, assembly or packaging processes preferred. Necessary to have keen attention to detail and demonstrate from previous work experiences. Preferred experience with aseptic technique and operating filling equipment or with assembly or packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipment preferred. Basic understanding of Microsoft Office Suite. Demonstrates strong interpersonal, cross-cultural, communication, negotiation and has a high emotional IQ. Exhibits confidence and strong problem-solving skills and demonstrates ingenuity, creativity and resourcefulness. Gains understanding from provided instructions and works towards established goals. Understands and listens to team members and stakeholders' needs while supporting a positive team environment. Possess a strong and effective communication style among peers and with management team Values and acts with integrity Shift Requirements: Physical Ability to perform physical requirements for entirety of shift (up to 10 hours): Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs Gowning and Environment Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA) Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire To be considered for the Fill/Finish Associate you must have a GED/High School diploma and previous work experience. Level is figured out based on qualifications relevant to the role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membe

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