Manufacturing Engineer II
Schott North America
About us
Your Contribution
Your Profile
Your Contribution
- Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholders
- Lead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global Engineering
- Manage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budget
- Prepare and maintain audit ready documentation aligned to US cGMP
- Operate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control Strategy
- Own change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure
- Lead/support validation and qualification for equipment, products, processes, etc.
- Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in place
- Support quality investigations
- Drive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times
- Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed
- Promote safety and EHS and adhere to all Company policies, procedures and guidelines
- Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent
- 4+ years in regulated manfuacturing
- Project management and CAPEX execution
- Six Sigma Green/Black Belt and/or PMP
- Validation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls
- Working knowledge of cGMP, ISO 9001, ISO 15378
- Knowledge and experience in leading new equipment/NPI validations
- Lean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)
- Tools: SAP, MS Project, MS TEAMS, Solidworks and Minitab
- Strong skills in MS Office
- Ability to read, write and speak English
- Team player with upbeat approach
- Excellent healthcare benefits including medical, dental and vision
- Short and long term disability
- Tuition reimbursement
- Paid time off
- Pet insurance
- Other supplemental benefits available upon election
Your Profile
- Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent
- 4+ years in regulated manfuacturing
- Project management and CAPEX execution
- Six Sigma Green/Black Belt and/or PMP
- Validation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls
- Working knowledge of cGMP, ISO 9001, ISO 15378
- Knowledge and experience in leading new equipment/NPI validations
- Lean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)
- Tools: SAP, MS Project, MS TEAMS, Solidworks and Minitab
- Strong skills in MS Office
- Ability to read, write and speak English
- Team player with upbeat approach
- Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholders
- Lead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global Engineering
- Manage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budget
- Prepare and maintain audit ready documentation aligned to US cGMP
- Operate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control Strategy
- Own change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure
- Lead/support validation and qualification for equipment, products, processes, etc.
- Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in place
- Support quality investigations
- Drive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times
- Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed
- Promote safety and EHS and adhere to all Company policies, procedures and guidelines
Vacancy posted 18 hours ago
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