Operational Excellence Engineer

JOB QUALIFICATIONS:

• Bachelor’s degree in engineering (Industrial, Chemical, Mechanical, Pharmaceutical), Life Sciences, Statistics, or a related technical discipline required; advanced degree preferred
• Certified Lean Six Sigma Black Belt from a recognized body (ASQ, IASSC, or accredited corporate program) required; Master Black Belt certification or candidacy preferred
• Minimum 5–8 years of progressive experience in manufacturing, engineering, or operational excellence, including at least 3 years leading formal Lean Six Sigma projects
• Experience in OTC pharmaceutical, nutraceutical, food, or other FDA-regulated manufacturing strongly preferred; familiarity with solid dose, liquids, creams/ointments, or packaging operations preferred
• Strong working knowledge of FDA regulations and cGMP guidelines, including 21 CFR Parts 210/211 and OTC monograph requirements
• Demonstrated mastery of DMAIC, Lean tools (VSM, 5S, SMED, TPM, standard work, kanban, kaizen), and change management methodology
• Advanced proficiency in statistical analysis and software such as Minitab, JMP, or equivalent; capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and SPC
• Working knowledge of OEE, capacity modeling, line balancing, and process cycle efficiency
• Working knowledge of change control, deviation/CAPA, validation, and risk assessment processes as they apply to process improvement
• Experience extracting and analyzing data from ERP, MES, LIMS, and historian systems; proficiency with Excel and data visualization tools such as Power BI or Tableau preferred
• Working knowledge of computer system validation principles, including ISPE GAMP 5 software categorization, FDA Computer Software Assurance (CSA) risk-based methodology, 21 CFR Part 11, and ALCOA+ data integrity expectations
• Experience defining user requirements, executing IQ/OQ/PQ or UAT test scripts, and supporting validation deliverables for systems or digital tools supporting manufacturing operations
• Familiarity with electronic batch records, automated data capture, and digital manufacturing/Industry 4.0 concepts preferred
• Proven ability to lead cross-functional teams without direct authority, influence at all organizational levels, and manage multiple concurrent projects
• Excellent written and verbal communication, facilitation, and executive presentation skills
• Strong financial acumen, including the ability to build and validate benefit cases with Finance

POSITION RESPONSIBILITIES:

Project Leadership & Execution

• Lead a portfolio of complex, cross-functional Black Belt projects from charter through control, delivering committed financial and operational benefits
• Apply the DMAIC methodology rigorously: define problem and scope, validate measurement systems, analyze root cause with statistical evidence, pilot and implement solutions, and establish sustainable controls
• Partner with site and functional leadership to identify, scope, prioritize, and charter improvement opportunities aligned to business objectives
• Manage project scope, timeline, resources, and risks; escalate barriers and report status to the Vice President, Operational Excellence and site leadership
• Quantify and validate project benefits with Finance, tracking hard savings, cost avoidance, and capacity gains through realization

Analytics & Problem Solving

• Perform advanced statistical analysis including capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and control charting to drive fact-based decisions
• Design and deploy statistical process control for critical process parameters and quality attributes, establishing limits, monitoring plans, and reaction rules
• Lead structured root cause investigations for chronic yield loss, downtime, rework, scrap, right-first-time failures, and repeat deviations
• Build and maintain operational dashboards and metrics — OEE, throughput, yield, RFT, changeover time, cost per unit — to expose performance gaps and improvement opportunities

Lean Deployment & Operating System

• Facilitate value stream mapping, kaizen events, and rapid improvement workshops across manufacturing, packaging, warehouse, and laboratory value streams
• Deploy Lean tools including 5S, standard work, SMED/changeover reduction, TPM, visual management, and material flow optimization
• Support development and sustainment of the site's daily management system, tiered accountability meetings, and problem-solving routines
• Drive waste elimination and cycle time reduction while protecting product quality, compliance, and patient safety

Computer Systems, Data & Digital Improvement

• Identify, scope, and lead improvement projects that leverage computer systems and digital tools to eliminate manual processes, reduce transcription error, and improve data availability across operations
• Serve as business process owner or requirements author for system enhancements, configuration changes, reports, and dashboards supporting Operational Excellence, partnering with Technical Services and IT for technical delivery
• Define user and functional requirements, build traceability to process needs, and participate in design reviews for system changes affecting operational processes
• Apply a GAMP 5 and FDA CSA risk-based approach to determine the appropriate validation rigor for system changes, distinguishing between high-risk GxP functionality requiring scripted testing and low-risk functionality suitable for unscripted or exploratory testing
• Author and execute test cases including user acceptance testing, and support IQ/OQ/PQ execution for systems and digital tools introduced through improvement projects, submitting deliverables for independent Quality review and approval
• Ensure data integrity and ALCOA+ principles are designed into improved processes, including audit trail adequacy, electronic signature use, user access controls, and record retention
• Validate spreadsheets, statistical models, and analytical tools used for GxP decision-making in accordance with site procedures and GAMP 5 Category classification
• Assess the validation and data integrity impact of process changes on interfaced systems such as ERP, MES, LIMS, historian, and quality systems
• Partner with Technical Services on periodic review, change control, and system lifecycle activities where operational process changes are involved

Quality & Regulatory Compliance

• Ensure all improvements affecting validated processes, equipment, utilities, materials, or documentation are executed through Change Control with Quality Assurance review and approval
• Assess regulatory, validation, and product quality impact of proposed changes in partnership with Quality, Regulatory Affairs, and Technical Services
• Support deviation investigations and CAPA effectiveness through structured problem-solving methodology and statistical evidence
• Author and revise SOPs, batch record steps, and work instructions resulting from improvement initiatives, routing through the document control process
• Support regulatory inspections and customer audits by providing process data, trending, and improvement documentation as requested

Capability Building & Coaching

• Train, coach, and mentor Green Belts, Yellow Belts, supervisors, and frontline teams in Lean Six Sigma tools and structured problem solving
• Serve as project sponsor or technical advisor for Green Belt projects, reviewing methodology rigor and validating results
• Develop and deliver training curriculum supporting the enterprise skills matrix and career pathing framework
• Champion a continuous improvement culture by recognizing contributions, sharing best practices, and standardizing successful solutions across PLD plants

Cross-Plant Standardization

• Replicate proven improvements across sites to build consistency in process, standard work, and performance expectations
• Participate in enterprise Operational Excellence forums to share learnings and align on common methodology, metrics, and definitions

PHYSICAL REQUIREMENTS:

• Occasionally lift objects weighing up to 25 pounds
• Climb stairs when needed
• Stand and walk on the manufacturing floor for extended periods during observations, kaizen events, and time studies
• Sit for long periods of time
• Occasionally stoop, kneel or crouch
• Use hands and arms to reach for, grasp and manipulate objects
• Access manufacturing, packaging, warehouse, and laboratory areas, including gowning and PPE as required
• Occasional travel to other PLD sites as required