Ossium Health
Associate Director of Engineering
Indianapolis, Indiana, United States · Director · Full-time
Sponsorship not specifiedDetected 37 days ago
SQLData VisualizationProject ManagementSupply ChainProcess ImprovementGMPFDA RegulatoryLeadershipCommunication
About the role
- About the Job This is a high-impact leadership role at the center of our manufacturing and technical operations.
- The position reports directly to the SVP of Manufacturing Operations.
- Our Equal Employment Opportunity Policy Statement and the Know Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment.
Responsibilities
- Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
- Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
- 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
- Identifying and prioritizing capital investments to support production growth
- Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness
- Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
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
- Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
- Proven track record of improving equipment reliability and reducing unplanned downtime
- Experience with root cause analysis, FMEA, and SOP development
- Travel (domestic and international) when required ( In your first six months some projects you'll work on include:
Nice to have
- 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)
- Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
Compensation
- Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
Benefits
- Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.
Equal opportunity
- Employer/Veterans/Disabled
- If reasonable accommodation is needed, please contact our People Team at careers@ossiumhealth.com or 650-285-0603.
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