Associate Director of Engineering

Ossium Health; Indianapolis (IN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

Four weeks of PTO annually

Employer paid life insurance

Gym membership reimbursements

Job summary

Ossium Health in Indianapolis is seeking an Associate Director of Engineering to lead the engineering team within our manufacturing operations. This role is critical for ensuring equipment and processes support high-quality production while maintaining compliance with regulatory standards.

The ideal candidate will possess a degree in engineering, extensive experience in the biotech sector, and proven leadership capabilities. The position offers competitive benefits, including stock options and a generous PTO policy.

Qualifications

• 8 years of experience in pharmaceutical or biotech manufacturing or 12 years in a regulated environment.
• 4 years managing engineers or technical staff.
• Strong knowledge of CGMP/CGTP requirements.

Responsibilities

• Lead and develop an engineering team.
• Own equipment lifecycle management.
• Ensure engineering compliance with CGMP/CGTP.

Skills

People management

Project management

CGMP/CGTP knowledge

Root cause analysis

Communication skills

Education

Bachelor’s degree in Engineering

Tools

Computerized maintenance management systems (CMMS)

Business intelligence tools

Job 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

In your first six months some projects you’ll work on include

• Assessing current equipment reliability, PM effectiveness, and engineering KPIs
• Implementing a new CMMS software platform
• Identifying and prioritizing capital investments to support production growth
• Standardizing engineering documentation and technical standards
• Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

We offer a full slate of employee benefits including

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually, 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, sexual orientation, gender identity, gender expression, or any other protected characteristic. Our Equal Employment Opportunity Policy Statement and the Know Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

If reasonable accommodation is needed, please contact our People Team at [e-mail] or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.

Equal Opportunity Employer/Veterans/Disabled