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Greenville, North Carolina, United States
Onsite
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Senior Operational Excellence and Digital Specialist
Drug Product Division (DPD) | Greenville, North Carolina
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
As a Senior PPI Business System Specialist, you will deliver measurable improvements at our Greenville pharmaceutical manufacturing site through the Practical Process Improvement (PPI) Business System and DPD One Way, the Drug Product Division approach to consistent operating practices.
This hands-on role combines manufacturing-floor problem solving, independent project delivery and team coaching. You will translate site priorities into sustained improvements in throughput, overall equipment effectiveness (OEE), right-first-time performance, deviation reduction, cycle time, service and cost of goods sold, while protecting safety and compliance.
· Build a prioritized pipeline of site PPI and digital opportunities for your assigned area, aligned with site annual operating plans and DPD priorities. Observe processes, identify constraints and develop project/initiative charters using divisional templates, with clear scope, owners, baselines and success criteria.
· Deploy and sustain DPD One Way visual management, Tier 1 and Tier 2 daily accountability, KPI reviews, escalation routines and leader standard work. Coach and train teams in daily tier accountability and independently apply KPI management and frontline coaching.
· Use A3 problem solving, Six Sigma DMAIC, root-cause analysis and structured experimentation to address losses and variation. Apply statistical process control (SPC) and process capability analysis, including Cpk, using Minitab or equivalent tools within approved procedures.
· Partner with Operations, Quality, Engineering, Maintenance, Tech Transfer and Supply Chain to remove constraints. Work with sterile process experts on production line losses, aseptic interventions, contamination risks and batch-release delays, supporting deviation and CAPA investigations as appropriate.
· Facilitate Kaizen events and independently apply value stream and process mapping, Gemba observation, 5S, the eight wastes, standard work, level loading and material flow. Improve OEE through quick changeover, setup preparation, mistake proofing and maintenance diagnostics with total productive maintenance (TPM).
· Lead assigned initiatives from charter through implementation, stabilization and sustainment. Manage schedules, resources and dependencies; maintain risks, assumptions, issues and decisions; and escalate barriers with mitigation options and clear requests for decisions. Ensure applicable change controls, procedure updates, training and validation are completed before implementation.
· Coach operators, team leaders and managers at the point of work. Assess stakeholder and training needs, communicate changes and verify adoption. Incorporate approved standard work, centerlines and critical process parameters into daily routines, sharing proven practices across the PPI network.
· Support business cases with Finance and process owners, defining assumptions, measurement methods and benefit owners. Document baselines, implementation, stabilization and sustained benefits; provide accurate KPI and Finance-validated savings inputs to monthly site and divisional reviews.
· Support approved digital solutions for operational performance. Independently map digital processes, identify use cases and work with digital specialists on analytics, connected shop-floor tools and collaboration. Confirm data readiness and consistent KPI definitions, and support onboarding and user adoption.
· Verify that improvements remain effective after project closure through adoption measures, clear process ownership and follow-up performance reviews. Embed solutions into tier routines and standard work to prevent one-off gains.
· A primarily onsite role in Greenville, North Carolina, with regular manufacturing-floor engagement and hands-on work with operating teams.
· Collaboration with line and functional leaders, aligned with DPD PPI and Digital standards. The immediate focus is site execution, with opportunities to support broader deployment and coaching as needs evolve.
· Travel of 0–15% as business needs require.
· Work in a GMP manufacturing environment, following applicable safety, gowning, contamination-control and site procedures.
· A bachelor’s degree with approximately 8 years of relevant experience, or an advanced degree with approximately 6 years, is preferred.
· Engineering, Science, Operations, Business or related disciplines are preferred. Equivalent combinations of education, experience and demonstrated capability will be considered.
· Lean Six Sigma Black Belt certification is required, supported by a multi-year track record of delivering Kaizen improvements and DMAIC projects with measurable, sustained operational and financial results.
· Demonstrated success delivering hands-on Lean, Six Sigma or operational excellence improvements in operations, with measurable operational and financial results sustained after implementation.
· Experience working directly with operators and supervisors to improve daily management and standard work, with the ability to contribute quickly in a complex, fast-paced operating environment.
· Sterile pharmaceutical manufacturing experience is strongly preferred. Relevant experience in pharma, other regulated manufacturing or similarly complex operations will also be considered.
· Practical experience leading statistical analyses, including SPC and process capability, and translating findings into effective countermeasures.
· Experience leading cross-functional projects through implementation and sustained adoption, including planning, risk management, benefits tracking and team coaching. Project management certification is a plus.
· Familiarity with change management approaches such as Prosci or Kotter and Agile fundamentals is preferred; relevant certification is advantageous.
· Ability to connect shop-floor observations and data to a clear problem statement, verified causes and effective countermeasures.
· Operational credibility, constructive conflict management and the ability to influence without direct authority, role-model effective leadership and build ownership with frontline teams.
· Strong facilitation, coaching and communication skills in English, with the ability to explain technical findings clearly and collaborate across functions.
· Working knowledge of strategy deployment, business and financial performance, and project time and scope management; ability to prioritize work and validate benefits with Finance.
· Ability to improve processes while respecting quality, patient safety and regulatory requirements.
· Proficiency in Excel and PowerPoint and practical familiarity with operations systems and digital tools, including Power BI, MES, CMMS, eQMS, digital performance management, and collaboration platforms.
· Practical experience using approved AI tools such as ChatGPT to create agents and reusable workflows for operational analysis, problem solving and productivity.
