Manufacturing Engineer II

Manufacturing Engineer II (sterile)

COMPANY: SCHOTT Pharma USA (Lebanon, PA) has been providing advanced solutions and services to the global pharmaceutical and biotechnology industries for over 100 years. SCHOTT Pharma USA offers an extensive and scientifically proven product portfolio including vials, syringes, cartridges and Fast Track Kits, for the safe storage and administration of injectable drugs worldwide.

ATTRACTIVE SKILLS/EXPERIENCES:

• Bachelor’s Degree in Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials Engineering (required)
• Six Sigma Certifications and/or PMP (preferred)
• Experience (4+ years) in a regulated manufacturing setting (Pharma; Bio Tech; 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), Solid Works 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

SUMMARY / RESPONSIBILITIES: This 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. Other potential duties/expectations include (but not limited to)…

• 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