Lead GMP Manufacturing Inspector

Manufacturing Technician IV, Lead - Inspection (Days)

Location:

West Chester Township, Ohio

Compensation: $26 - 40 USD / hour

About The Role

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 Inspection floor activities. The Technician serves as a technical resource for the team, performs advanced-level documentation review, maintains qualification standards, and drives continuous improvement in partnership with Process Facilitators and Engineers.

Operations:

• Lead and monitor inspection process activities to ensure successful operations on the production floor.
• Perform inspection activities as needed to support floor coverage and qualification maintenance.
• 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 for the Process Execution Team (PET).

Documentation & Compliance:

• 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.
• Access and print SOPs and forms via ECMS as required, using current revisions.
• Follow job-related safety procedures including PPE use, LOTO, ergonomics, and chemical handling.
• Use process documents including SOPs, forms, and batch records to guide own work in accordance with SOPs and cGMPs.

Training & Development:

• Maintain all required certifications and qualifications for the assigned work area.
• Serve as a technical resource for the team, providing subject-matter guidance to production and mechanical technicians.
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Support team members in maintaining required qualifications and certifications.
• Collaborate with Process Facilitators and Engineers on inspection floor initiatives.
• Apply strong problem-solving and prioritization skills to make independent decisions and provide guidance to team members on daily production activities.
• Support deviation investigations, CAPA execution, and SOP revisions as the inspection floor SME.
• Attend and actively participate in daily Tier 1 meetings.

Education & Experience:

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including demonstrated expertise across all inspection types and equipment and prior experience leading floor execution.
• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
• Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
• Strong organizational, analytical, and problem-solving skills with the ability to independently prioritize operations.
• Ability to effectively read, write, speak, and understand English to communicate technical information cross-functionally.
• Experience providing on-the-job training or technical guidance to peers while fostering a culture of compliance and continuous improvement.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Background:

• High school graduate, vocational school graduate, or equivalent.
• 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Prior inspection experience.
• Experience in metrics tracking and reporting.
• Experience contributing to inspection process improvements, deviation investigations, and qualification programs.
• Experience working in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

Physical & Work Environment:

• This role is…