Senior Manager, Engineering
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
About Ossium
Ossiums 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
- Bachelors 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 (<10%) to support other sites
In your first six months some projects youll 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
Required Experience:
Senior Manager
