Principal Engineer, Aseptic Equipment & Process

Bausch + LombUS-SC-Greenville, SC
11hOnsite

About The Position

The Principal Aseptic Equipment & Process Engineer will provide leadership and support of critical, value-added initiatives aligned with site priorities to implement variety of engineering projects for Lens Care Solutions manufacturing to increase machine efficiency and OEE, reduce cost, improve quality, and address critical obsolescence issues. Specify, design, and implement a portfolio of projects requiring cross-functional partnering across multiple disciplines within the organization. Position will also support day-to-day uptime needs of process equipment across the manufacturing site.

Requirements

  • BS or MS degree in Mechanical, Industrial, Electrical, or Manufacturing Engineering. Advanced degree preferred.
  • 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.
  • Strong technical leadership capabilities with a proven ability to develop clear project objectives and work well in multi-disciplinary teams to solve complex problems.
  • Proven track record of delivering to objectives.
  • 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.

Nice To Haves

  • Lean 6-Sigma Green Belt certification or equivalent, Certified PMP a plus

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.
  • 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.

Benefits

  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
  • Bausch + Lomb Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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