About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:18.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>About us</b></H2> </div><div><p><span style="font-size:11.0pt"><span style="font-family:Calibri"></span></span></p> </div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:18.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Your Contribution</b></H2> </div><div><ul> <li>Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholders</li> <li>Lead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global Engineering</li> <li>Manage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budget</li> <li>Prepare and maintain audit ready documentation aligned to US cGMP</li> <li>Operate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control Strategy</li> <li>Own change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure </li> <li>Lead/support validation and qualification for equipment, products, processes, etc.</li> <li>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</li> <li>Support quality investigations</li> <li>Drive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times </li> <li>Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed </li> <li>Promote safety and EHS and adhere to all Company policies, procedures and guidelines </li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:18.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Your Profile</b></H2> </div><div><ul> <li>Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent</li> <li>4+ years in regulated manfuacturing </li> <li>Project management and CAPEX execution</li> <li>Six Sigma Green/Black Belt and/or PMP</li> <li>Validation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls </li> <li>Working knowledge of cGMP, ISO 9001, ISO 15378</li> <li>Knowledge and experience in leading new equipment/NPI validations</li> <li>Lean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)</li> <li>Tools: SAP, MS Project, MS TEAMS, Solidworks and Minitab</li> <li>Strong skills in MS Office </li> <li>Ability to read, write and speak English</li> <li>Team player with upbeat approach </li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:18.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Your Benefits</b></H2> </div><div><ul> <li>Excellent healthcare benefits including medical, dental and vision</li> <li>Short and long term disability </li> <li>Tuition reimbursement </li> <li>Paid time off</li> <li>Pet insurance </li> <li>Other supplemental benefits available upon election</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:18.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Please feel free to contact us</b></H2> </div><div></div></div></div>