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, FATSAT planning, cost tracking, forecasting, and accuracy. Deliver fiscal year plans 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.
Leads 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 spare parts 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, checklists 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 manufacturing. Project management and CAPEX execution. Six Sigma Green, Black Belt, and/or PMP. Validation and QMS URS, FMEA, VMP, IQOQPQPV 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 an 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.
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Job Segment: Manufacturing Engineer II
Job Segment: Six Sigma, Black Belt, Lean, Six Sigma, Pharmaceutical, Supply Chain Management, Science, Operations