Manufacturing Engineer II

SCHOTT AG•Lebanon, PA

28d

About The Position

About us 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 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 Your Benefits 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 Please feel free to contact us

Requirements

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
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

Nice To Haves

Six Sigma Green/Black Belt and/or PMP

Responsibilities

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