SUMMARY:The Operational Excellence Engineer serves as the site's certified Lean Six Sigma Black Belt, leading complex, data-driven improvement projects that deliver measurable gains in yield, throughput, quality, cost, and service across OTC pharmaceutical manufacturing and packaging operations. Operating as a senior individual contributor within Operational Excellence, this role leads cross-functional DMAIC and Lean initiatives, applies advanced statistical analysis to solve chronic and high-impact problems, and builds continuous improvement capability by coaching Green Belts, Yellow Belts, and frontline teams. The role also drives digital and data-enabled improvement, partnering with Technical Services and IT to define requirements, and applying GAMP 5 and FDA Computer Software Assurance principles to ensure systems and analytical tools used in GxP decision-making are appropriately validated. All improvements are executed in a cGMP-compliant manner, with changes to validated processes, systems, equipment, and documentation routed through Change Control and approved by Quality Assurance.
Work Schedule: Monday - Friday Starting Salary: $91,000JOB 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
BENEFITS:PLD is a proud equal opportunity employer offering many corporate benefits, including:
- Medical and Dental Benefits
- Vision
- 401K with employer match
- Group Life Insurance
- Flex Spending Accounts
- Paid Time Off and Paid Holidays
- Tuition Assistance
- Corporate Discount Program
- Opportunities to Flourish Within the Company
The EEO statement needs to be included in the detailed description... PL Developments is an Equal Opportunity Employer. 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.
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