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 Bachelor's 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