We are currently looking for a Fill/Finish Operator. Regeneron optimally manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Fill/Finish Operators perform tasks vital to support aseptic filling manufacturing processes. They work individually, and as part of a team, to support operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for biological products. Our Operators seek to understand and develop proficiency in a wide range of processes or procedures of growing complexity.
As a Fill/Finish Operator, a typical day might include the following:
Provides support for the operation of, and may independently operate, a mix of manual and brand new automated equipment such as washers, autoclaves, filling equipment, labelers, cartoners, syringe and device assembly machines according to applicable procedures based on training and operator level.
Ensures stock levels are maintained.
Ensures automated machines are replenished at a sufficient rate to continue operation.
Performs cleaning activities in support of line clearance.
Provides assistance to Biotech Production Specialists (BPSs) as they perform routine product sampling as well as non-routine sampling for various engineering or validation studies.
Completes and reviews batch records and logbooks in accordance with cGMP standards and follows written procedure.
Completes batch records within the electronic record system (MES).
Completes training and follows appropriate gowning requirements for controlled and/or classified work areas.
Ensures all tasks are performed in a manner consistent with cGMP SOPs and safety standards.
Ensures process areas are stocked with crucial materials, equipment and components.
Reconciles components and product according to SOP and Batch Record requirements.
Assists BPSs with equipment start-up, commissioning and validation activities.
May assist Biotech Production Specialists (BPSs) with troubleshooting in case of equipment/system failure.
May capture and process data to support investigations associated with filling, packaging or assembly activities.
Maintains and ensures accurate documentation of all training.
Assists with training of new employees as advised.
Assists and chips in all areas of filling manufacturing, labeling, packaging and assembly as needed.
Travel (domestic and international) may be required to support new equipment purchases and/or training.
Must be able to lift/push/pull at least 40lbs.
You have knowledge of cGMP manufacturing environment and familiarity with cGMP filling, assembly or packaging processes preferred.
You prefer 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.
You have a basic understanding of Microsoft Office Suite.
You demonstrate strong interpersonal, cross-cultural, communication, negotiation and has a high emotional IQ.
You exhibit confidence and strong problem-solving skills and demonstrate ingenuity, creativity and resourcefulness.
You gain understanding from provided instructions and work towards established goals.
You understand and listen to team members and partners’ needs while supporting a positive team environment.
You support the development and maintenance of a diverse and inclusive environment.
To be considered for the Fill/Finish Operator you must have the following; Level I - HS diploma/GED/Leaving Cert; 0-2 yrs experience, college degree may be preferred; Level II - HS diploma/GED/Leaving Cert; 2+ yrs experience, college degree may be preferred; Level III - HS diploma/GED/Leaving Cert; 4+ yrs experience, college degree may be preferred; Level IV - HS diploma/GED/Leaving Cert; 6+ yrs experience, college degree may be preferred.
Level is figured out based on qualifications relevant to the role
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic