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

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

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