Manufacturing Engineer II - Process & Validation Lead

SCHOTT AG; Lebanon (Lebanon County); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Healthcare benefits

Disability coverage

Paid time off

Job summary

SCHOTT AG in Lebanon, PA seeks a seasoned Engineering professional to own project scopes, schedules and budgets, driving CAPEX and cross-functional execution with Production, Quality, Maintenance and Supply Chain.

You will validate and qualify equipment, manage change controls, and ensure GMP-compliant documentation and ISO-aligned processes while leading continuous improvement to improve OEE, uptime and cycle times.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent.
• 4+ years in regulated manufacturing.
• 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.
• Tools: SAP, MS Project, MS TEAMS, SolidWorks and Minitab.

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 accruals; 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)- initiation, risk assessment, execution plan, verification of effectiveness 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

Skills

Project management

CAPEX execution

Validation

QMS

cGMP knowledge

Team player

Education

Bachelor's degree in Engineering

Tools

SAP

MS Project

MS TEAMS

SolidWorks

Minitab

Job description

SCHOTT AG in Lebanon, PA seeks a seasoned Engineering professional to own project scopes, schedules and budgets, driving CAPEX and cross-functional execution with Production, Quality, Maintenance and Supply Chain.

You will validate and qualify equipment, manage change controls, and ensure GMP-compliant documentation and ISO-aligned processes while leading continuous improvement to improve OEE, uptime and cycle times.