OPEX Process Specialist: Lean Manufacturing Optimizer

Simtra BioPharma Solutions; Bloomington (CA); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions in Bloomington, IN, seeks an OPEX Process Specialist to maximize production efficiency and drive process improvements. This role is highly visible on the floor with strong interaction with the production team.

The position requires applying Lean/Six Sigma to improve equipment effectiveness, lead cross-functional improvement initiatives, and standardize setup, operation, and troubleshooting procedures for production, maintenance, and training personnel.

Qualifications

• BS degree in science or technology preferred or 5+ years of pharmaceutical manufacturing experience
• 3+ years experience in a regulated industry/environment
• Excellent problem-solving skills with ability to provide solutions
• Excellent oral and written communication skills
• Six Sigma Green Belt certification or higher preferred

Responsibilities

• Evolve into a SME for assigned manufacturing processes/equipment including syringe/vial lines, lyophilizers, isolators, and packaging equipment
• Serve as advisor to building leadership relative to assigned equipment and processes
• Use Lean/Six Sigma tools (SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s) to drive improvements in OEE
• Participate and lead cross-functional continuous improvement initiatives (Kaizens) impacting performance and conversion loss
• Manage multiple projects and work with cross-functional teams
• Responsible for standardization/training of set-up, operating, and troubleshooting procedures for production, maintenance, and training personnel
• Ability to create, manage and approve master change controls and work orders
• Participate in and/or author investigation/analysis of complex issues and determine root cause and implement corrective actions

Skills

Microsoft Office Suite

Problem solving

Communication skills

Six Sigma Green Belt

Education

BS degree in science or technology

Tools

Microsoft Office Suite

Job description

Simtra BioPharma Solutions in Bloomington, IN, seeks an OPEX Process Specialist to maximize production efficiency and drive process improvements. This role is highly visible on the floor with strong interaction with the production team.

The position requires applying Lean/Six Sigma to improve equipment effectiveness, lead cross-functional improvement initiatives, and standardize setup, operation, and troubleshooting procedures for production, maintenance, and training personnel.