Mindlance
Overview
Biologics Operator I is responsible for the production of highly expensive and sensitive Biological Parenteral product. The role includes working in aseptic high-level, silent environments and carrying out repetitive tasks such as syringes inspection. The incumbent may be required to tolerate sitting in the same position for long periods and work in low light, with exposure to cold rooms and variable temperatures. Responsibilities
Clean and prepare equipment, formulate solutions, perform process testing, filtering and transfer of solutions. Provide support in the aseptic filling of small volume syringes with the use of RABS (Restricted Access Barrier System) and inspection of the filled product in its final package. Operate equipment such as parts washers, autoclaves, CIP (Cleaning in Place) systems, SIP (Sterilization in Place) systems, formulation tanks, filter integrity testing machines, and magnetic stirrers. Make inventory of materials and parts necessary for manufacturing; perform process tests as required; monitor alarm systems. Assemble equipment and perform cleaning and sterilization procedures; work on the cleaning, preparation and sterilization of manufacturing equipment. Comply with Good Manufacturing Practices (GMP) and standard procedures (SOPs); inform the supervisor about any event that occurred during the work shift. Work and operate in the context of the SVP area; participate in qualification and validation activities; receive and verify materials for the manufacture of the final product. Assist in the formulation of biological parenteral product and supervise process samples such as pH, density, and osmolality; inspect equipment to verify operation within established parameters. Carry out cleaning operations, pressure testing, sterilization of equipment, integrity checks of filters and RABS gloves, filtration of solutions, aseptic filling, and product inspection. Monitor processes through computerized systems and visual inspection; recognize deviations and take action to avoid process deviations and product loss. Keep detailed records of operations, batch records, logbooks, and perform required inventory transactions manually or electronically. Handle and dispose of hazardous and non-hazardous materials according to established procedures; attend and complete internally trained training on industrial hygiene, occupational safety, GMP, SARA, CHAP, BOP and others. Use required PPE and report incidents or unsafe conditions in the work area; maintain clean facilities to preserve aseptic conditions. Carry out production documentation accurately and on time following good documentation practices and GMP; audit batch records and logbooks as required. Diagnose and resolve events or exceptions of highly complex equipment and processes via HMI/PLC interfaces; have understanding and basic knowledge of equipment and processes with automated systems. Attend to other areas within SVP as required or necessary; provide assistance to operations in control, management and disposal of domestic, biomedical and hazardous waste as applicable, ensuring compliance with federal and local regulations. Qualifications/Requirements
Note: The description emphasizes responsibilities, work environment, and GMP compliance; specific formal qualifications are not listed in the provided content. The candidate should be able to perform duties in aseptic, cold, and low-light conditions, operate specialized equipment, and adhere to GMP/SOP requirements. Work Environment & Other
Attend internally trained training on industrial hygiene, occupational safety, and GMP-related practices. Use PPE as required and follow plant procedures to maintain aseptic conditions. EEO: Min dlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans
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Biologics Operator I is responsible for the production of highly expensive and sensitive Biological Parenteral product. The role includes working in aseptic high-level, silent environments and carrying out repetitive tasks such as syringes inspection. The incumbent may be required to tolerate sitting in the same position for long periods and work in low light, with exposure to cold rooms and variable temperatures. Responsibilities
Clean and prepare equipment, formulate solutions, perform process testing, filtering and transfer of solutions. Provide support in the aseptic filling of small volume syringes with the use of RABS (Restricted Access Barrier System) and inspection of the filled product in its final package. Operate equipment such as parts washers, autoclaves, CIP (Cleaning in Place) systems, SIP (Sterilization in Place) systems, formulation tanks, filter integrity testing machines, and magnetic stirrers. Make inventory of materials and parts necessary for manufacturing; perform process tests as required; monitor alarm systems. Assemble equipment and perform cleaning and sterilization procedures; work on the cleaning, preparation and sterilization of manufacturing equipment. Comply with Good Manufacturing Practices (GMP) and standard procedures (SOPs); inform the supervisor about any event that occurred during the work shift. Work and operate in the context of the SVP area; participate in qualification and validation activities; receive and verify materials for the manufacture of the final product. Assist in the formulation of biological parenteral product and supervise process samples such as pH, density, and osmolality; inspect equipment to verify operation within established parameters. Carry out cleaning operations, pressure testing, sterilization of equipment, integrity checks of filters and RABS gloves, filtration of solutions, aseptic filling, and product inspection. Monitor processes through computerized systems and visual inspection; recognize deviations and take action to avoid process deviations and product loss. Keep detailed records of operations, batch records, logbooks, and perform required inventory transactions manually or electronically. Handle and dispose of hazardous and non-hazardous materials according to established procedures; attend and complete internally trained training on industrial hygiene, occupational safety, GMP, SARA, CHAP, BOP and others. Use required PPE and report incidents or unsafe conditions in the work area; maintain clean facilities to preserve aseptic conditions. Carry out production documentation accurately and on time following good documentation practices and GMP; audit batch records and logbooks as required. Diagnose and resolve events or exceptions of highly complex equipment and processes via HMI/PLC interfaces; have understanding and basic knowledge of equipment and processes with automated systems. Attend to other areas within SVP as required or necessary; provide assistance to operations in control, management and disposal of domestic, biomedical and hazardous waste as applicable, ensuring compliance with federal and local regulations. Qualifications/Requirements
Note: The description emphasizes responsibilities, work environment, and GMP compliance; specific formal qualifications are not listed in the provided content. The candidate should be able to perform duties in aseptic, cold, and low-light conditions, operate specialized equipment, and adhere to GMP/SOP requirements. Work Environment & Other
Attend internally trained training on industrial hygiene, occupational safety, and GMP-related practices. Use PPE as required and follow plant procedures to maintain aseptic conditions. EEO: Min dlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans
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