Manufacturing Engineer II

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

• Bachelors 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