Synergetics · 12 hours ago
Principal Engineer, Aseptic Equipment & Process
Greenville, SC
Full-time
Onsite
Lead/Staff
10+ years expBausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people. The Principal Aseptic Equipment & Process Engineer will provide leadership in implementing engineering projects to improve manufacturing efficiency, quality, and cost for Lens Care Solutions.
Health CareHealth DiagnosticsManufacturingMedical DevicemHealth
No H1B
Responsibilities
As technical Subject Matter Expert (SME) lead improvement projects and support daily operation of process equipment systems including packaging line equipment (cartoners, bundlers, case-packers, palletizers, printers, labellers, vision systems, robotics)
Use root cause analysis (RCA) tools to systemically diagnose and resolve complex manufacturing technical issues and develop technical solutions to improve process performance, quality, and cost. Engage cross-disciplined resources to support implementation of improvements aligned with site priorities. Provide on-going technical support including validation, training and the creation of required documentation for new manufacturing equipment and processes
Use failure mode analysis to improve equipment and process reliability and design
Develop and lead Engineering projects designed to reduce waste, improve process capability, process reliability, increase Overall Equipment Effectiveness (OEE), improve quality and manage capacity as required
Define, manage and track, key performance indicators (KPI’s) for equipment reliability and capital equipment projects
Develop data acquisition and performance measuring techniques to gather and analyse critical data necessary to execute actions that improve product cost, quality and manufacturing reliability. Use operational data and performance metrics to analyse critical parameters necessary to identify and drive Overall Equipment Efficiency (OEE) and reliability improvements
Manage engineering projects including scope, resource planning, budget activities, validation and project execution timeline. Communicate status of project milestones to key stakeholders
Advise management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations
Maintain a working knowledge of new technologies which may improve operations and develop recommendations and plans accordingly. Identify innovative technical and process solutions that drive the desired performance in cost, quality, compliance, customer service and revenue
Qualification
Required
BS or MS degree in Mechanical, Industrial, Electrical, or Manufacturing Engineering
Minimum 10 years of relevant industrial experience in Pharmaceutical or Medical Device regulated manufacturing engineering with emphasis on Process & Packaging Equipment Design, process improvements, and GMP CapEx execution
Lean 6-Sigma Green Belt certification or equivalent
Proven experience working in ISO 5 rated clean room and aseptic fill and finish experience, up to date on Annex 1 regulations and requirements
Proven experience in manufacturing Process and Packaging equipment design and technology improvements in a cGMP environment including equipment qualification and process validation
Strong technical leadership capabilities with a proven ability to develop clear project objectives and work well in multi-disciplinary teams to solve complex problems
Solid analytical and problem-solving skills
Demonstrated proficiency in use of Process Excellence and Lean tools and Design for Six Sigma DFSS, (DMAIC, DOE, VSM, RCA, FMEA, etc.)
Proven ability to work autonomously within a fast-paced, multitasking environment and effective at working across organizational boundaries
Excellent verbal and written communication skills and ability to influence at all levels of the organization
Strong conflict resolution, teamwork and negotiation skills, with proven ability to influence without authority
Proficient with the Microsoft office suite of tools including Microsoft Project, Visio, etc
Working knowledge of CAD software (e.g. SolidWorks™) and GD&T concepts
Proven experience of using RCA tools to solve challenging technical problems, developing corrective and preventative actions
Preferred
Advanced degree preferred
Certified PMP a plus
Benefits
Employee Benefits: Bausch + Lomb
Company
Synergetics
As Synergetics becomes Bausch + Lomb Retina, keep following us to learn why our newly formed partnership is all about you.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-02-10Acquired
1990-04-06IPO
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