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Senior Manager, Engineering

Ossium HealthIndianapolis, Indiana

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Overview

Schedule
Full-time
Career level
Director
Remote
On-site
Benefits
Health Insurance
Dental Insurance
Vision Insurance

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 Senior Manager 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 careers@ossiumhealth.com or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.
Principals / direct applicants only please. Recruiters, please do not contact this job poster. 
Equal Opportunity Employer/Veterans/Disabled

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FAQs About Senior Manager, Engineering Jobs at Ossium Health

What is the work location for this position at Ossium Health?
This job at Ossium Health is located in Indianapolis, Indiana, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Ossium Health?
Employer has not shared pay details for this role.
What employment applies to this position at Ossium Health?
Ossium Health lists this role as a Full-time position.
What experience level is required for this role at Ossium Health?
Ossium Health is looking for a candidate with "Director" experience level.
What benefits are offered by Ossium Health for this role?
Ossium Health offers following benefits: Health Insurance, Dental Insurance, Vision Insurance, Disability Insurance, Life Insurance, Paid Holidays, Paid Vacation, Paid Sick Leave, 401k Matching/Retirement Savings, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Ossium Health?
You can apply for this role at Ossium Health either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.