Biologic Operator I Position Available In Somerset, New Jersey

Job Title:

Biologic Operator I Job Description We are seeking an entry-level Biologic Operator I to join our team, working Wednesday through Saturday from 1pm to 11:30pm. This role involves working in aseptic high-level silent environments, performing repetitive tasks such as syringe inspections, and operating in conditions with low light and cold temperatures ranging from 15 to 25 degrees, with occasional exposure to temperatures as low as 2 to 8 degrees. Responsibilities Conduct production of highly expensive and sensitive biological parenteral products. Perform cleaning and preparation of equipment, solution formulation, process testing, filtering, and transfer of solutions. Provide support in aseptic filling of small volume syringes using Restricted Access Barrier Systems (RABS) and inspect the filled product in its final packaging. Operate different equipment such as parts washers, autoclaves, CIP and SIP systems, formulation tanks, filter integrity testing machines, and magnetic stirrers. Make inventory of materials and parts necessary for manufacturing and perform process tests as required. Monitor alarm systems and assemble equipment for cleaning and sterilization procedures. Comply with Good Manufacturing Practices (GMP) and standard procedures (SOPs). Inform the supervisor of any events occurring during the work shift. Work aseptically in the formulation of biological parenteral products and perform process samples such as pH, density, and osmolality. Inspect equipment to ensure operation within established parameters. Carry out cleaning operations, pressure testing, sterilization of equipment, integrity of filters and RABS gloves, filtration of solutions, aseptic filling, and product inspection. Monitor processes through computerized systems and visual inspection, recognizing deviations to alert and take corrective actions. Receive and verify materials for final product manufacturing. Participate and assist in qualification and validation activities within the SVP area. Maintain detailed records of operations during shifts, including batch records and logbooks, and perform inventory transactions. Handle and dispose of hazardous and non-hazardous materials according to established procedures. Attend and complete training on industrial hygiene, occupational safety, and GMPs. Use required personal protective equipment (PPE) and notify supervisors of incidents or unsafe conditions. Operate efficiently to achieve optimal product performance. Complete production documentation accurately and on time, following good documentation practices. Audit batch records and logbooks of production as required. Maintain clean facilities to ensure aseptic conditions. Diagnose and resolve complex equipment and process issues using systems such as Human Machine Interface (HMI) and Process Logics Controls (PLC). Assist in other SVP areas as necessary. Provide assistance in managing and disposing of domestic, biomedical, and hazardous waste, ensuring compliance with regulations. Essential Skills Production experience Inspection skills Aseptic technique proficiency Knowledge of Good Manufacturing Practices (GMP) Biology degree 1-2 years of relevant work experience Additional Skills & Qualifications Understanding and basic knowledge of automated systems Ability to sit in the same position for extended periods Ability to work in cold environments Strong attention to detail and documentation skills Work Environment The role operates Wednesday through Saturday from 1pm to 11:30pm. You will work in aseptic high-level silent environments, performing repetitive tasks such as syringe inspections. The work involves low light conditions and cold temperatures ranging from 15 to 25 degrees, with occasional exposure to temperatures as low as 2 to 8 degrees. Personal protective equipment (PPE) is required, and adherence to safety protocols is mandatory.