Operational Excellence Specialist

About the Job

The Operational Excellence (OpEx) Specialist is a key driver of performance, compliance, and continuous improvement within the 503B sterile compounding production environment. This role partners closely with Production, Quality Assurance, Quality Control, Supply Chain, Validation, and Engineering to identify operational gaps, eliminate waste, strengthen process capability, and ensure the site consistently meets regulatory expectations and business objectives. The OpEx Specialist applies Lean, Six Sigma, and data‑driven problem‑solving methodologies to optimize throughput, reduce defects, enhance aseptic discipline, and support a culture of operational maturity.

• Lead and facilitate Lean initiatives (5S, standard work, visual management, value stream mapping) across ISO‑7 and ISO‑5 operations.
• Identify bottlenecks in compounding, filtration, filling, and inspection workflows; implement sustainable solutions that improve flow and reduce cycle time.
• Conduct time studies, labor modeling, and capacity analysis to optimize staffing and equipment utilization.
• Develop and maintain KPIs and dashboards that drive daily performance management.

• Lead structured problem‑solving (DMAIC, 5‑Why, Fishbone, Fault Tree) for deviations, complaints, and recurring operational issues.
• Partner with QA to ensure CAPAs are data‑driven, effective, and closed on time.
• Support investigations related to aseptic behavior, environmental monitoring trends, filter validation gaps, and equipment performance.

• Develop and refine SOPs, batch records, and work instructions to ensure clarity, consistency, and audit readiness.
• Translate complex technical requirements into technician‑friendly procedures without compromising compliance.
• Support creation of visual aids, job aids, and training materials for production personnel.

• Partner with Validation and Engineering to support new equipment introduction, process changes, and facility modifications.
• Assist in risk assessments (FMEA, hazard analysis) and ensure operational controls are embedded into validated processes.
• Support filter validation, surrogate matrix justification, and process capability assessments for sterile filtration and aseptic operations.

• Analyze production data to identify trends, inefficiencies, and improvement opportunities.
• Build models for throughput, yield, scrap, and labor efficiency; present insights to leadership.
• Monitor and report on key operational metrics including batch success rate, deviation frequency, and inspection performance.

• Coach supervisors and technicians on Lean principles, problem‑solving, and best practices in aseptic operations.
• Facilitate Gemba walks, tier meetings, and continuous improvement workshops.
• Promote a culture of accountability, right‑first‑time execution, and proactive issue identification.

• Identify and deliver OPEX savings through scrap reduction, yield improvement, labor optimization, and process efficiency.
• Reduce cost per unit by improving throughput, minimizing rework, and optimizing resource utilization.

• Bachelor’s degree in Engineering, Life Sciences, Operations, or related field.
• 3+ years of experience in pharmaceutical manufacturing, ideally in a 503B, 503A, or cGMP sterile environment.
• Working knowledge of Lean, Six Sigma, and structured problem‑solving tools.
• Strong understanding of aseptic processing, sterile filtration, and cleanroom operations.
• Ability to analyze complex data sets and translate insights into actionable improvements.
• Excellent communication and facilitation skills

• Lean Six Sigma Green Belt or Black Belt certification.
• Experience supporting regulatory inspections (FDA, State Boards of Pharmacy).
• Familiarity with PDA TR 26, USP /, and 503B outsourcing facility requirements.
• Experience with filter validation, process mapping, and operational modeling.

The ideal OpEx Specialist is:

• Analytical — able to dissect processes and uncover…