SCHOTT Pharma · 16 hours ago
Manufacturing Engineer II
Lebanon, PA
Full-time
Onsite
Mid Level
$95K/yr - $105K/yr
4+ years expSCHOTT Pharma USA has been providing advanced solutions and services to the global pharmaceutical and biotechnology industries for over 100 years. The Manufacturing Engineer II (sterile) will lead validated, compliant CAPEX projects and new product/equipment introductions that improve OEE, reduce scrap, and integrate seamlessly into production, on-time and on-budget.
Advanced MaterialsBiotechnologyHealth CareManufacturingPharmaceutical
Hiring Manager
Jonathan Starr
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
Perform other duties as assigned
Qualification
Required
Bachelor's Degree in Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials Engineering
Experience (4+ years) in a regulated manufacturing setting (Pharma; BioTech; Medical Device; Primary Packaging)
Experience leading Project/CAPEX (up to $500K)
Experience with Validation and QMS (URS; FMEA; VMP; IQ/OQ/PQ) - Author/Review protocols/reports, manage deviations/CAPA and change control
Experience leading new equipment / NPI validations (FAT/SAT; commissioning; start-up)
Demonstrated knowledge of Lean/CI principles (5S; Kaizen; DMAIC; Root Cause; 5-Why; Fishbone)
Demonstrated knowledge with SAP, MS Project (Gantt / Critical Path), SolidWorks and Minitab
Proven knowledge of cGMP and ISO Standards (9001; 15378)
Demonstrated communication skills (written / oral) including the ability to read/speak English
Ability and willingness to work in fast-paced, matrix structured organization
Preferred
Six Sigma Certifications and/or PMP
Company
SCHOTT Pharma
Drug containment and delivery solutions for injectable drugs - Vials, Syringes, Cartridges, Ampoules
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Andreas Reisse
CEO
Recent News
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2026-01-16
Precedence Research
2025-12-01
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