OPEX Process Specialist - Lean Six Sigma for Biopharma Ops

Simtrabps; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with -

Paid Holidays and PTO

Parental Leave and more

Education Assistance Program

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions, based in Bloomington, Indiana, seeks an OPEX Process Specialist to maximize production efficiency on the manufacturing floor, collaborating with the production team. You will drive process improvements and equipment effectiveness, reporting to the Associate Director of OPEX and supporting cross-functional teams with standardization, training, and change controls.

Join a team committed to quality, continuous improvement, and patient health, with comprehensive benefits

Qualifications

• BS degree in science or technology or 5+ years pharma manufacturing in lieu of BS
• 3+ years experience in a regulated industry/environment
• Microsoft Office proficiency (Word, Excel, Outlook)
• Strong problem-solving and communication skills
• Six Sigma Green Belt or higher preferred

Responsibilities

• Evolve into SME for syringe/vial lines, lyophilizers, isolators, and packaging equipment
• Advise building leadership on equipment and processes
• Use Lean/Six Sigma tools (SPC, CPk, Statistics, Pareto, Fishbone, 5-Whys) to drive OEE improvements
• Lead cross-functional continuous improvement initiatives (Kaizens) affecting performance
• Manage multiple projects with cross-functional teams
• Standardize/train setup, operating, and troubleshooting procedures
• Create/manage/approve master change controls and work orders
• Investigate complex issues to determine root causes and corrective actions

Skills

BS degree or 5+ years pharma

3+ years in regulated industry

MS Office proficiency

Problem solving

Six Sigma Green Belt

Education

BS in science/technology

Job description

Simtra BioPharma Solutions, based in Bloomington, Indiana, seeks an OPEX Process Specialist to maximize production efficiency on the manufacturing floor, collaborating with the production team. You will drive process improvements and equipment effectiveness, reporting to the Associate Director of OPEX and supporting cross-functional teams with standardization, training, and change controls.

Join a team committed to quality, continuous improvement, and patient health, with comprehensive benefits