Director of Engineering - GMP Manufacturing & Reliability

Ossium Health, Inc.; Indianapolis (IN); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

Four weeks of PTO accrued annually 11+

Employer paid life insurance and long‑

term disability

Gym membership/recreational sports

Job summary

Ossium Health, Inc. is seeking an Associate Director of Engineering to lead the engineering and maintenance function supporting GMP manufacturing at our Indianapolis facility.

You will guide equipment reliability, qualification, and lifecycle management while partnering with Production, Quality, MSAT, and Facilities to enable safe, high‑quality product supply. The role emphasizes technical leadership, cross‑functional collaboration, and continuous improvement in a regulated environment,

Qualifications

• Bachelor's degree in Engineering and 8+ years 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

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.

Skills

Leadership

CGMP/CGTP knowledge

Equipment qualification (IQ/OQ/PQ)

Root cause analysis

Project management

Communication

SOP development

Regulatory inspections (FDA/EMA)

Education

Bachelor's degree in Engineering

8+ years in pharma/biotech OR 12+ years in regulated manufacturing

Tools

CMMS

Tableau

Power BI

SQL

Job description

Ossium Health, Inc. is seeking an Associate Director of Engineering to lead the engineering and maintenance function supporting GMP manufacturing at our Indianapolis facility.

You will guide equipment reliability, qualification, and lifecycle management while partnering with Production, Quality, MSAT, and Facilities to enable safe, high‑quality product supply. The role emphasizes technical leadership, cross‑functional collaboration, and continuous improvement in a regulated environment,