Senior Manager, Engineering

Senior Manager, Engineering position at Ossium in Indianapolis, Indiana, United States. Lead the engineering and maintenance function, ensure equipment, processes, and systems remain reliable, compliant, and scalable. Partner with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as a technical problem solver and strategic enabler of safe, high-quality, and reliable product supply.

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

Benefits

• 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