Manufacturing Technician II - DAP; Nights) Hardware

Manufacturing Technician II - DAP (Nights) Oversee night packaging line and ensure compliant batch records for on-time release

Location:

Blue Ash, Ohio

Compensation: $22 - 32 USD / hour

A career at Resilience is more than just a job – it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

The Manufacturing Technician II reports to a Supervisor/Manager, Manufacturing and performs a variety of manufacturing tasks in Controlled/Non-Classified areas in accordance with cGMPs, supporting Packaging operations. Responsibilities include operating packaging equipment, performing in-process monitoring, line clearances, cosmetic inspection, cleaning, and completing batch record entries.

Note:

Blue Ash, Device Assembly, Night Shift

Operations

• Perform the duties of operating assigned machinery: service machines with materials, monitor equipment status, reintroduce materials, manually palletize finished materials, and ensure smooth product flow.
• Start-up machinery including equipment setup, recipe selection, data entry on SCADA and HMI; make minor adjustments and perform critical sensor challenges.
• Perform manual packaging tasks as required including hand packaging and rework of in-process and finished material.
• Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) to safely move, store, or deliver material.
• Perform visual quality inspection and sampling of in-process materials; promptly escalated concerns to Lead and Management as needed.
• Perform minor troubleshooting including clearing minor jams and identifying equipment defects; escalating to the Lead and Management as needed.
• Perform inventory control and reconciliation activities using SAP and WES.
• Perform cleaning, housekeeping, and line clearance activities for assigned areas to maintain a cGMP environment.

Documentation & Compliance

• Perform batch record and GMP documentation entries; perform mathematical computations as required.
• Follow job-related safety procedures including PPEs, LOTO, ergonomics, and material/chemical/waste handling, spill controls and human safety.
• Support lean activities and process improvement work including 5S, problem-solving, and manual data collection.
• Execute protocols as required as part of equipment qualification and process validation work.

Training & Development

• Provide flexible support to other areas of the Manufacturing Team as needed.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Attend and actively participate in daily Tier 0 meetings.

Minimum Qualifications

• Prior experience in a regulated manufacturing environment.
• Working knowledge of product security controls and material handling equipment.
• Demonstrated documentation and data entry skills, including accurate completion of batch records and logbooks.
• Basic mathematical skills, including the ability to perform routine calculations (e.g., weights, measures, conversions).
• Ability to effectively read, write, speak, and understand English to interpret SOPs, batch records, and work instructions.
• Ability to follow written procedures and work instructions with minimal supervision, escalating issues as needed.
• Basic problem-solving skills and the ability to identify deviations or inconsistencies in processes or documentation.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Experience working in a lean manufacturing environment.
• Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good…