Manufacturing Technician IV, Lead - DAP (Night Shift)

Resilience•West Chester, OH

4d•Onsite

About The Position

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.

Requirements

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.
All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Nice To Haves

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.

Responsibilities

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.
Acquire and maintain all required certifications and qualifications for the assigned work area.
Attend and actively participate in daily Tier 0 meetings.