| Location | Lebanon, PA |
Responsibilities Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholdersLead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global EngineeringManage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accruals; deliver fiscal year plan on time and on budgetPrepare and maintain audit ready documentation aligned to US cGMPOperate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control StrategyOwn change controls (local and global) – initiation, risk assessment, execution plan, verification of effectiveness and closureLead/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 placeSupport quality investigationsDrive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle timesMentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where neededPromote safety and EHS and adhere to all Company policies, procedures and guidelinesQualifications Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manufacturingProject management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controlsWorking knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS OfficeAbility to read, write and speak EnglishTeam player with upbeat approachBenefits Excellent healthcare benefits including medical, dental and visionShort and long term disabilityTuition reimbursementPaid time offPet insuranceOther supplemental benefits available upon election#J-18808-Ljbffr