Manufacturing Technician IV, Lead - DAP (Nights)

Resilience•West Chester, OH

About The Position

The Manufacturing Technician IV, Lead reports to a Supervisor/Manager on the Manufacturing floor and leads complex Packaging floor activities. The role 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. The position supports production operations, including equipment start-up and operation, manual packaging, line clearances, inventory control, equipment qualification, and process validation. It also involves reviewing and completing GMP documentation, maintaining required qualifications, training team members, leading daily Tier 0 meetings, and helping resolve operational issues. This is a primarily non-sedentary role that may involve climbing, kneeling, repetitive motion, temperature changes, and moving objects using up to 100 pounds of force. The role also involves use of personal protective equipment and participation in an occupational health program. The employee must pass an eye exam during onboarding.

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.
Ability to work independently and resourcefully to resolve complex production issues and guide team members in a fast-paced production environment.
Ability to review and ensure the accuracy of critical GMP documentation and batch records.
Ability to work with limited supervision, independently determine daily priorities, and make informed decisions under pressure.
Strong organizational, analytical, and problem-solving skills.
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 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.
Ability to pass an eye exam during onboarding.
Ability to meet the physical demands of a primarily non-sedentary role, including climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
Ability to use required personal protective equipment and participate in an occupational health program, which may include medical assessment, surveillance, vaccination, and testing.

Nice To Haves

High school graduate, vocational school graduate, or equivalent.
Four or more 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, and generative AI language tools such as Claude.

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 for equipment qualification and process validation.
Ensure production-floor work follows SOPs and cGMPs.
Support lean activities, including 5S, problem-solving, and serving as a continuous-improvement project resource.
Complete advanced-level batch record and GMP documentation entries, including complex or non-routine documentation, and guide team members on documentation accuracy.
Review operational SOPs, forms, and batch records for accuracy; propose revisions and update documents where needed.
Maintain required certifications and qualifications for the assigned work area.
Serve as a technical resource and subject-matter support for production and mechanical technicians.
Act as a certified on-the-job trainer for assigned equipment and process tasks, training and supporting team members.
Collaborate with Management and Engineers on packaging-floor initiatives.
Make independent decisions and provide guidance on daily operational activities using problem-solving and prioritization skills.
Prepare and lead daily Tier 0 meetings.
Adhere to the Quality Management System, including the Quality Manual, Quality Policy, SOPs, cGMPs, and other applicable regulations and standards.