Manufacturing Technician IV, Lead - DAP (Night Shift)
$54,080–$84,240 year
On-siteWest Chester, Ohio, United States
Job Summary
Lead complex packaging floor operations by monitoring process activities, performing equipment start-ups, and executing line clearances. Manage inventory control and reconciliation via SAP and WES while ensuring all work adheres to SOPs and cGMPs. Provide advanced-level documentation review for batch records and GMP entries, offering guidance to team members on accuracy. Serve as a technical resource and certified OJT trainer for production and mechanical technicians, supporting lean initiatives like 5S and continuous improvement projects. Attend daily Tier 0 meetings and collaborate with management on packaging floor initiatives. Work a night shift schedule with flexible hours, including potential overtime requests.
Required Qualifications
- 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
- Ability to pass eye exam during onboarding
- 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.
Desired Qualifications
- 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
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