Manufacturing Technician IV, Lead - Device Assembly (Blue Ash - NIGHT SHIFT

Manufacturing Technician IV, Lead

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 IV, Lead reports to a Supervisor/Manager on the Manufacturing floor and leads complex Packaging floor activities. The Technician serves as a technical resource for the team, performs advanced-level documentation review, drives continuous improvement, and collaborates with Management and Engineers to ensure compliant and efficient packaging operations.

• Lead and monitor complex process activities to ensure successful operations on the production floor.
• Perform technician tasks as required including start-up, equipment operation, manual packaging, and line clearances.
• Perform inventory control and reconciliation activities using SAP and WES.
• Execute protocols as required as part of equipment qualification and process validation work.
• Ensure work requirements are followed on the production floor in accordance with SOPs and cGMPs.
• Support lean activities including 5S, problem-solving, and serving as CI project resource.
• Perform advanced-level batch record and GMP documentation entries on the production floor, including complex or non-routine documentation; provide guidance to team members on documentation accuracy.
• Review process documents such as operational SOPs, forms, and batch records for accuracy.
• Maintain all required certifications and qualifications for the assigned work area.
• Serve as a technical resource for the team, providing subject-matter support to production and mechanical technicians.
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Collaborate with Management and Engineers on packaging floor initiatives.
• Apply strong problem-solving and prioritization skills to make independent decisions and provide guidance to team members on daily operational activities.
• Attend and actively participate in daily Tier 0 meetings.

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Advanced knowledge of cGMP requirements and quality systems, including deviations, change control, and data integrity.
• Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members in a fast-paced production environment.
• Proven ability to review and ensure accuracy of critical GMP documentation and batch records.
• Demonstrated ability to work with limited supervision and independently determine daily priorities, with strong organizational, analytical, and problem-solving skills to make informed decisions under pressure.
• Applied quantitative skills sufficient to interpret production data, evaluate trends, and support investigations and continuous improvement work.
• Experience providing on-the-job training to peers in a manufacturing environment.
• Ability to effectively read, write, speak, and understand English to communicate technical information cross-functionally.
• Ability to work effectively as part of a team in a fast-paced production environment.
• High school graduate, vocational school graduate, or equivalent.
• 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Prior experience serving as a subject-matter resource or trainer on the production floor.
• Experience in a lean manufacturing environment.
• 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,…