Associate Director of Engineering at Ossium Health

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

0.0

Posted On

15 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

People Management, CGMP/CGTP Compliance, Equipment Qualification, Validation, Change Control, Root Cause Analysis, FMEA, SOP Development, Project Management, Capital Project Management, Lean Six Sigma, CMMS, Automation, Business Intelligence, Technical Leadership, Reliability Engineering

Industry

Biotechnology Research

Description

About Ossium Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. About the Job This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Associate Director of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow. You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site. This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations. Required Qualifications Bachelor’s degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment 4+ years of people management experience leading engineers or technical staff Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls Proven track record of improving equipment reliability and reducing unplanned downtime Strong project management, documentation, and communication skills Experience with root cause analysis, FMEA, and SOP development This position is based full time onsite in our Indianapolis facility Preferred Qualifications Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas Familiarity with computerized maintenance management systems (CMMS) Experience leading capital projects and facility expansions Lean or Six Sigma certification Experience implementing automation and digital engineering solutions Experience interacting with regulatory inspectors (FDA, EMA, or equivalent) Expertise in business intelligence and analytics (Tableau, Power BI, SQL) Key Responsibilities Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel Be a key member of our Site Operations Team, ensuring reliable supply of product to patients Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures Lead root cause investigations related to equipment, utilities, and facility systems Drive data-based reliability improvements using trend analysis and KPIs Support inspection readiness and represent Engineering during regulatory audits Develop long-term facility and infrastructure strategy aligned with commercial growth plans Travel (domestic and international) when required (

Responsibilities

Lead the engineering and maintenance functions to ensure reliable, compliant, and scalable GMP/GTP manufacturing operations. Oversee equipment lifecycle management, capital projects, and reliability programs to support product supply and commercial growth.