Manufacturing Process Improvement Specialist

3 days ago

San Diego, California, United States Revvity Full time
Job Summary

The Manufacturing Engineer I will play a key role in driving continuous improvement activities in Manufacturing and across Operations. This position will lead the efforts to optimize business processes and systems by assessing business needs and proposing, developing, and implementing equipment, process, procedural and software solutions and improvements.

Key Responsibilities
  • Provide project management and leadership to support and implement continuous improvement activities in different Manufacturing departments and the wider Operations group (Supply Chain, QC, MFG, FAC, OPS ENG)
  • Provide analytical support to operational functions and drive new improvement initiatives
  • Responsible for rapid changeover activities including principles, target setting, and leading successful efforts reducing changeover time to achieve challenging objectives
  • Follow systematic problem-solving process through Kaizen methodology, Participate in Kaizens as subject matter expert, as a facilitator, or as a general participant
  • Support the development of organizational performance metrics, measures of improvement in key metrics
  • Support daily visual management program, +QDIP, and support the creation of Gemba walk style walkabouts in our Cell Culture, Purification, Conjugation, Form/Fill/Finish Departments as well as GMP, MCBIO, Proteogenomics and SCM groups.
  • Apply Lean methodologies to eliminate operational waste, reduce cycle time, elimination of bottlenecks, streamline process workflow, and optimize business planning and inventory strategy
  • Collaborate and communicate cross-functionally to assist Manufacturing and Operations teams to solve operational issues such as lot to lot variability in quality and yield, quick changeovers, optimized planning, and scheduling processes
  • Create tools and reports to facilitate the quick identification of process delays, quality issues, or bottlenecks
  • Support the Operational Excellence program
  • Training, mentor, lead, and engage the Manufacturing team on the concepts of continuous improvement and lean manufacturing
  • Prepare and present project concepts, updates, finished project reports, and other updates, as needed
  • Lead, track, and report on quarterly progress of OKRs and Goals/Objectives for Manufacturing and related groups
  • Document and track the continuous improvement project pipeline or funnel
  • Support other Manufacturing and Operations projects and activities as needed.
Requirements
  • BS Degree is required, preferably in engineering, business, or related field
  • 3+ years of experience in an Operational Excellence function is required - preferably in the Biotech, life sciences, medical device industries, or other FDA regulated industries
  • Lean Six Sigma (Yellow or Green Belt) or similar certification or demonstrated experience in a manufacturing environment is required
  • Demonstrated proficiency and practical application of Continuous Improvement tools including Lean Manufacturing, Lean Six Sigma DMAIC, Kaizen, 6S, Value Stream Mapping, A3, Root Cause Analysis, SPC, Quality Tools, Single Piece Flow
  • Ability to develop, maintain, and report key performance metrics required
  • Excellent problem-solving, organizational, project management, analytical, and critical thinking skills including high discretion/judgment in decision making
  • Excellent communication, cross-functional project, and team leadership skills are required
  • Excellent written and verbal communication skills with the ability to convey complex information in a clear, concise manner
  • Excellent project management and project tracking skills, including written reports and presentations
  • Manage large complex programs that will accelerate operational, productivity, and customer experience improvements across the business operation organization.
Preferred Qualifications
  • Working knowledge of cGMP and other standard practices within the life sciences industry
  • Knowledge and understanding of FDA regulations, 21CFR 820, ISO13485, and other ISO standards related to life science, diagnostics, and medical device manufacturing
  • Experienced in mono and polynomial antibody and recombinant protein processing and manufacturing techniques and technologies
  • Master's Degree in related field
  • Lean Six Signa Black or Master Blackbelt certification
What We Offer
  • Medical, Dental, and Vision Insurance Options
  • Life and Disability Insurance
  • Paid Time-Off
  • Parental Benefits
  • 401k with Company Match
  • Employee Stock Purchase Plan

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