Senior Manager, Engineering

Ossium Health•Indianapolis, IN

20h•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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)

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