Manufacturing Associate I (Packaging) - Rotating 1st & 2nd Shift

Amneal • Chicago, IL

18d • Onsite

About The Position

The Drug Product Manufacturing Associate I is a regular, full-time, non-exempt employee at Kashiv BioSciences, LLC, in Chicago, Illinois. The position manufactures biotechnology products for clinical and commercial human use while complying with company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other applicable government requirements.

The role performs packaging operations in GMP clean rooms and laboratories, including equipment operation, product and packaging inspections, documentation, material handling, and maintaining clean-room conditions. The position requires rotating shift work; overtime, holidays, and weekends may be required based on process requirements.

Requirements

• Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field, preferred; alternatively, 1–4 years of industry experience is required.
• Basic verbal and written English communication skills, including the ability to understand technical information, procedures, batch records, and other English-language documents.
• Excellent interpersonal skills.
• Ability to operate complex systems and equipment in accordance with cGMP, SOPs, and safety guidelines under minimal supervision.
• Basic ability to identify problems and troubleshoot equipment and manufacturing processes.
• Ability to work independently within SOPs and prescribed guidelines or as a team member, and to follow detailed directions.
• Computer skills, including experience with systems such as POMS, LIMS, SAP, or NetSuite; ability to use word processing, spreadsheets, and data management tools.
• Knowledge of GMP and safety requirements.
• Knowledge of biotechnology operations and equipment such as aseptic filtration systems, aseptic sampling, filter integrity testing, stirrer plates, floor scales, peristaltic pumps, and weigh scales.
• Ability to move around the facility to reach equipment; push and pull containers.
• Ability to lift at least 25 pounds; frequent movement of 25–50 pounds on carts and movement of 100–250 pounds with assistance.
• Ability to stand for long periods and perform occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching, as well as frequent repetitive motions.
• Ability to produce neat, legible, extensive manufacturing documentation in accordance with current Good Manufacturing and Good Documentation Practices.

Nice To Haves

• Experience operating packaging machines, including labeling, autoinjector, blister packaging, serialization, and aggregation equipment.

Responsibilities

• Perform line inspection and line clearance in the packaging area.
• Operate syringe labeling, label counting, blister packaging, autoinjector assembly and labeling, check-weighing, semi-automatic cartonating, serialization, aggregation, and tamper-evident sealing equipment according to applicable SOPs.
• Visually inspect labeled syringes, labeled autoinjector devices, blister packs, printed cartons, and shippers for defects.
• Submit samples and participate in investigations when needed.
• Manually pack syringes and other required components into cartons.
• Check carton weights to ensure components are not missing; pack acceptable cartons into shippers and palletize them.
• Submit documents and material requests to the appropriate department to begin packaging operations.
• Verify drug product syringes before packaging begins.
• Electronically record process steps when required, and accurately and promptly complete logbooks, batch records, and other cGMP documentation.
• Remove and dispose of soiled or expired items, rejected syringes, and materials from the area.
• Maintain packaging rooms and surrounding areas within required clean-room manufacturing conditions.
• Report shift nonconformances and events to the Supervisor.
• Follow safety, cGMP, company policies, practices, and procedures.
• Perform other assigned functions, including manufacturing and visual inspection.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Flexible benefits program for eligible positions, including health and insurance benefits.
• Significant 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree