Operational Excellence Specialist Job at Fagron (Canton)

Operational Excellence Specialist

Fagron

Location:
United States , Canton

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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.

Job Responsibility:

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

Requirements:

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

Nice to have:

Lean Six Sigma Green Belt or Black Belt certification
Experience supporting regulatory inspections (FDA, State Boards of Pharmacy)
Familiarity with PDA TR 26, USP <797>/<800>, and 503B outsourcing facility requirements
Experience with filter validation, process mapping, and operational modeling

What we offer:

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Additional Information:

Job Posted:
March 25, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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