MilliporeSigma · 4 hours ago
Process Engineer 2
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$67K/yr - $101K/yr
5+ years expMilliporeSigma is a global leader in Healthcare, Life Science, and Electronics, committed to innovating with science and technology. The Process Engineer 2 role involves providing technical oversight for commercial operations, managing technical projects, and serving as a primary contact for clients while ensuring regulatory compliance and continuous improvement initiatives.
BiotechnologyMedical DeviceHealthcareMedical
No H1B
Responsibilities
Provide technical engineering oversight for all phases of commercial operations, including bulk formulation, fill-finish (RABS/Isolator), and high-speed packaging
Lead the scale-up and transfer of new clinical and commercial products, ensuring seamless integration into existing production lines and equipment
Manage multiple concurrent technical projects valued up to $250K, overseeing the full lifecycle from capital appropriation and budgeting to execution and staffing
Serve as the primary technical point of contact for internal and external clients, coordinating deliverables across cross-functional departments and contractors
Act as a Subject Matter Expert (SME) to lead process investigations, identify root causes for deviations, and implement continuous improvement initiatives
Design and specify equipment for bulk processing and filling systems, including performing hydraulic, heat transfer, and material balance calculations
Author and update critical site documentation, including SOPs, P&IDs, electrical drawings, and validation protocols to ensure regulatory compliance
Develop and modify control loops and PLC ladder logic to optimize manufacturing equipment performance and process reliability
Qualification
Required
Bachelor's Degree in Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering or other Life Science or Engineering discipline
5+ years of work experience in pharmaceutical operations as validation engineer, process engineer, or project engineer
5+ years of work experience in US and European GMP requirements and FDA guidelines
Preferred
Master's Degree in Chemical or Biochemical Engineering
Strong Microsoft Suite, Microsoft Visio, and AutoCAD skills
Experience with Kepner-Tregoe
Experience with Root Cause Analysis methodology or FMEA
Experience with Minitab or JMP
Benefits
Health insurance
Paid time off (PTO)
Retirement contributions
Other perquisites
Company
MilliporeSigma
Together with our colleagues, customers and stakeholders, we impact life and health with science.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
David Nogales
Head of Technology Strategy
Recent News
2025-09-23
2025-06-20
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