About the Job

We’re hiring an Equipment Technician who will focus on critical equipment to ensure that our clinical production team has everything they need to process and bank life-saving bone marrow.  In this role, you’ll be responsible for a variety of facility and equipment cleaning, maintenance, installation, operation, and troubleshooting to keep operations running smoothly in our cGMP (current Good Manufacturing Practice) facility.  This is a hands-on role, and we’ll train you on Good Documentation Practices, preparing tools for sterilization, and other support tasks which are key for a biotech manufacturing facility. Restocking materials and reagents as well as cleaning equipment/tools and autoclaving may also be a part of your daily routine.

This role reports to the Facilities Manager, and will work closely with both the Facilities team and the Clinical Production team.

Required Qualifications

• High School Diploma
• Ability to solve technical and performance problems using information from a variety of sources
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This is an hourly, non-exempt role based in our Indianapolis facility
• We are currently hiring for Monday through Friday 8am - 5pm

Preferred Qualifications

• Experience working hands-on with laboratory/clinical equipment

Key Responsibilities

• Perform scheduled maintenance inspections and assurance inspections on equipment to ensure safe and effective operating conditions
• Assist with qualification of new equipment
• Test and calibrate components using a variety of manuals, troubleshooting techniques, and code requirements
• Perform routine preventative maintenance and calibrations of equipment
• Assist with cleaning, calibration, and maintenance of quality control, production, and research lab equipment, including non-routine maintenance and scheduling service or calibration with outside vendors as needed
• Assist in repair and replacement of complex medical equipment and systems
• Install and test a variety of medical and research equipment
• Diagnose equipment malfunctions with accuracy
• Perform activities in accordance with current GDP and cGMP 
• Recognize and communicate production and work environment issues/observations to supervisory staff in a timely manner

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

• Training on gowning and cleaning practices for the cleanroom support areas
• Shadowing Clinical Production personnel and observe processing 
• Assisting Clinical Production team in developing improved tool cleaning procedures
• Learning the basics of safety, sterility, and the general flow of our methods and operations
• Understanding our freezers (-80° & -190°) and how they operate, fill and alarm
• Gaining familiarity with switching out Co2 and LN2 tanks

Physical Requirements

• Requires training in blood borne pathogen safety measures; new hires will be given the option of Hepatitis B vaccination
• Requires standing, walking, pushing, kneeling, twisting and reaching
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals 
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time
• Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms

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

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 (<10%) to support other sites

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