Operational Excellence Specialist

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit member-driven public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

The Impact That You Will Make

The Operational Excellence Specialist is critical to the evolution of ARMI into a GMP Phase 1 manufacturing organization while ensuring Process Development is continually optimized. The Specialist works cross-functionally with Process Development Program Management Quality Control Quality Assurance and administrative teams to maintain operational readiness and drive continuous improvement. This role provides administrative support to the Operations Support team and maintains a strong daily presence in the laboratory and manufacturing spaces ensuring equipment readiness material availability issue identification / resolution and operational continuity through hands-on support.

Your Role

Equipment & Asset Management

• Track maintenance activities procurement needs vendor deliverables and other operational actions through completion.
• Provide basic troubleshooting and operational checks for laboratory manufacturing and facility equipment to ensure proper operation.
• Coordinate and support vendor visits service activities and contractor work including scheduling facility access escorts communication with internal stakeholders and verification of completed work.
• Lead the implementation and adoption of an equipment management platform including system configuration equipment data migration preventive maintenance workflows user onboarding training and ongoing process optimization.

Facility & Operational Readiness

• Coordinate cross-functional activities related to laboratory manufacturing equipment materials and facility readiness.
• Provides indirect leadership to the Operations Support internship program including onboarding training scheduling and day-to-day task coordination.
• Support emerging operational priorities special projects and unplanned needs across ARMIs facility ensuring continuity of operations and organizational readiness via a hands on problem solving focused approach
• Perform daily walkdowns of laboratory manufacturing and utility spaces to verify equipment status material availability cleanliness and operational readiness and proactively address or coordinate resolution of identified issues.
• Ensure cleanrooms and labs meet readiness requirements including equipment availability material staging and environmental conditions.
• Support procurement activities including purchase requests quotes orders delivery tracking Approved Material List management and supplier communications as requested
• Support inventory and materials management to ensure availability of laboratory and operational supplies.

Process Improvement & Documentation

• Support technical writing activities such as SOPs work instructions deviations CAPAs and other operational documentation.
• Develop maintain and improve operational processes tracking systems and documentation
• Identify and implement opportunities for process improvement standardization and operational efficiency across teams and facilities.

Your Skills and Experiences

• High school diploma or equivalent required.
• Minimum of 3 years of direct work experience in the cell therapy biopharmaceutical manufacturing medical device or other similar industries
• Proven ability to communicate and work with all levels within an organization and with external suppliers / contractors
• Technical proficiency with laboratory manufacturing and facility equipment including understanding of operation failures and maintenance requirements.
• Proficiency with Microsoft Office and/or other business and operational management systems.
• Demonstrated organizational skills and attention to detail.
• Exceptional written and verbal communication skills.
• Ability to be successful and navigate shifting priorities and business needs.

By applying I understand that any offer of employment is contingent upon the successful completion of a background check in accordance with applicable laws.

Required Experience:

IC