Operational Excellence Engineer

We need to output HTML fragment with sections: About the role? The posting includes a summary paragraph. Use

for each section heading. Must not repeat job title. Must not include Job ID. Must include only sections with real specific content. Must not include filler like "commensurate with experience". Must include Pay and Schedule only if posting actually states them. The posting includes "Work Schedule: Monday - Friday" and "Starting Salary: $91,000". So we need Pay and Schedule sections. Also Benefits section is present. Also maybe Qualifications, Responsibilities, Skills? The posting includes "Job Qualifications" and "Position Responsibilities". Also there is a list of qualifications and responsibilities. Also there is a "Physical Requirements" section; but we only have headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't say we must use exactly those; we can use those headings if content matches. We have Qualifications (Job Qualifications). Responsibilities (Position Responsibilities). Benefits. Pay. Schedule. Possibly About the role could be the summary paragraph. Requirements maybe not needed if we have Qualifications. Could combine Requirements and Qualifications? But we have Qualifications section already. Could also have Skills section derived from qualifications? Might be redundant. Better to include About the role (summary), Responsibilities, Qualifications, Benefits, Pay, Schedule. Possibly also Requirements? The qualifications already cover requirements. Could omit Requirements to avoid thin sections. The instruction: Prefer a few substantive sections over many thin ones. So we can omit Requirements if not needed. Also Skills maybe not needed as separate; qualifications cover skills. So we will output sections: About the role, Responsibilities, Qualifications, Benefits, Pay, Schedule. We must preserve all substantive information; not invent or summarize away detail. Must not repeat job title. Must not include boilerplate like EEO etc? Actually instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should remove the EEO statement and the "#HP1". Also remove "The EEO statement needs to be included in the detailed description..." and the actual EEO statement. Also remove "PL Developments is an Equal Opportunity Employer..." etc. Also remove any duplicated lines. Also remove "Benefits PLD is a proud equal opportunity employer offering many corporate benefits, including:"? Actually that line includes equal opportunity employer phrase; we need to remove EEO boilerplate but keep the benefits list. So we should strip the phrase "PLD is a proud equal opportunity employer offering many corporate benefits, including:" but keep the list after colon. However the list is after colon: "Medical and Dental BenefitsVision401K with employer matchGroup Life InsuranceFlex SpendingAccountsPaid Time Off and Paid HolidaysTuition AssistanceCorporate Discount ProgramOpportunities to Flourish Within the Company". The original text had no spaces between some items; we need to preserve the list items. We'll need to parse into list items. The original: "Medical and Dental BenefitsVision401K with employer matchGroup Life InsuranceFlex Spending AccountsPaid Time Off and Paid HolidaysTuition AssistanceCorporate Discount ProgramOpportunities to Flourish Within the Company". It seems missing spaces; we can separate by capital letters? Better to keep as is? Might be okay to keep as a single paragraph? But we need to use

• for any list of benefits. So we need to split into items. Let's manually split: 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. We'll produce
• for each. Now About the role: The summary paragraph: "PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. 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." We need to preserve all substantive info. We'll put that in

  under About the role. Responsibilities: The "Position Responsibilities" section includes multiple subsections: Project Leadership & Execution, Analytics & Problem Solving, Lean Deployment & Operating System, Computer Systems, Data & Digital Improvement, Quality & Regulatory Compliance, Capability Building & Coaching, Cross-Plant Standardization. We need to preserve all details. We'll output as

  • each responsibility bullet? The text is paragraph style with headings. We could treat each subsection as a
  • with its content. Or we could break into multiple
  • for each bullet within subsections. Simpler: each subsection as a
  • with its paragraph(s). We'll keep the headings inside
  • maybe as ? But we must output only HTML, no extra formatting beyond tags. We can include inside
  • . That's allowed. We'll preserve the text. Qualifications: The "Job Qualifications" block includes many bullet-like sentences separated by semicolons or line breaks. We'll split into list items. Let's extract each qualification: - 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 We'll put each as
  • . Benefits: list as earlier. Pay: Starting Salary: $91,000. We'll put in

    . Schedule: Work Schedule: Monday - Friday. We'll put in

    . We must not include any other sections like About the role? Already. Now produce HTML fragment:

    About the role

    ...

    Responsibilities

    • Project Leadership & Execution Lead a portfolio of complex, cross-functional Black Belt projects from charter through control, delivering committed financial and operational benefits... (continue full text)
    ... etc. We need to ensure we include all details from each subsection. Let's copy each subsection text exactly as in posting. From posting: **Project Leadership & Execution** Lead a portfolio of complex, cross-functional Black Belt projects from charter through control, delivering committed financial and operational benefitsApply the DMAIC methodology rigorously: define problem and scope, validate measurement systems, analyze root cause with statistical evidence, pilot and implement solutions, and establish sustainable controlsPartner with site and functional leadership to identify, scope, prioritize, and charter improvement opportunities aligned to business objectivesManage project scope, timeline, resources, and risks; escalate barriers and report status to the Vice President, Operational Excellence and site leadershipQuantify and validate project benefits with Finance, tracking hard savings, cost avoidance, and capacity gains through realization Note there are missing spaces after periods; we should preserve as is? Might be okay but we could add spaces for readability? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Adding spaces is not inventing content, just formatting; but could be considered altering. Safer to keep exactly as given, but the lack of spaces makes it hard to read. However we must output exactly the text; we can keep as is. We'll keep the exact string. **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 decisionsDesign and deploy statistical process control for critical process parameters and quality attributes, establishing limits, monitoring plans, and reaction rulesLead structured root cause investigations for chronic yield loss, downtime, rework, scrap, right-first-time failures, and repeat deviationsBuild 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 streamsDeploy Lean tools including 5S, standard work, SMED/changeover reduction, TPM, visual management, and material flow optimizationSupport development and sustainment of the site's daily management system, tiered accountability meetings, and problem-solving routinesDrive 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 operationsServe 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 deliveryDefine user and functional requirements, build traceability to process needs, and participate in design reviews for system changes affecting operational processesApply 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