Manufacturing Engineer II

Schott North America; South Lebanon Township (PA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Excellent healthcare benefits

Tuition reimbursement

Paid time off

Job summary

Schott North America is seeking a qualified Engineer to lead manufacturing projects, manage CAPEX, and ensure compliance with cGMP standards. The role requires a Bachelor's degree in Engineering and over 4 years of experience in regulated environments.

Key responsibilities include managing project scopes and budgets, supporting validation processes, and driving continuous improvement initiatives. Competitive healthcare benefits, tuition reimbursement, and paid time off are among the perks offered.

Qualifications

• 4+ years in regulated manufacturing.
• Ability to lead new equipment/NPI validations.
• Strong skills in MS Office.

Responsibilities

• Own project scopes, schedules and budgets.
• Lead cross functional execution with various departments.
• Prepare audit ready documentation.

Skills

Project management

Regulated manufacturing knowledge

Lean methodologies

Six Sigma Green/Black Belt

Strong MS Office skills

Education

Bachelor's degree in Engineering

Tools

SAP

MS Project

Solidworks

Job description

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

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
• 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

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