Siemens Healthineers · 2 weeks ago
Senior Process Engineer - Scale Up Facility
Tarrytown, NY
Full-time
Onsite
Mid, Senior Level
$120K/yr - $165K/yr
5+ years expSiemens Healthineers is a leader in medical technology, seeking a Senior Process Engineer to join their Scale Up Facility team in Tarrytown, NY. This role involves providing technical leadership for scale-up and technology transfer activities, mentoring junior staff, and driving process optimization and compliance in a regulated environment.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Lead scale-up and design transfer activities for immunoassay products, ensuring readiness for manufacturing
Provide technical leadership in troubleshooting, process characterization, and optimization
Mentor junior engineers and technicians, fostering technical growth and compliance culture
Support the wider R&D team with engineering expertise to accomplish site-wide goals
Take ownership of SUF infrastructure (Filling equipment, Lyophilizer, autoclave, temperature control units, Water purification systems, etc.). Keep equipment operating efficiently, manage repairs and upgrades, and ensure compliance with cGMP standards
Manage calibration, certification, and preventive maintenance program of all SUF inspection, measuring, and test equipment (IMTE) to ensure accuracy and reliability
Coordinate with external vendors for maintenance, repairs, and external calibration services; review certifications and reports
Administer REES temperature monitoring system for the site; coordinate with supplier and internal IT department to resolve issues
Lead and manage engineering projects from start to finish
Commission, develop operating procedures, and validate new laboratory and processing equipment
Drive continuous improvement initiatives to enhance reliability and efficiency
Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to ensure seamless technology transfer
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical) or related scientific discipline required; Master's degree preferred
Minimum 5+ years in process engineering, pilot facility engineering, or manufacturing engineering within a regulated environment
Strong knowledge of cGMP requirements and equipment validation
Strong knowledge of IMTE requirements
Proven ability to lead projects and mentor team members
Excellent analytical, problem-solving, and communication skills
Ability to influence stakeholders and manage vendor relationships
Experience with risk assessments and validation protocols
Preferred
Experience with lyophilization, filtration, liquid filling, and autoclaving processes
Experience with statistical process control, design of experiments, and other statistical techniques
Familiarity with digital tools for process monitoring and documentation
Experience with automation or digitalization initiatives in process environments
Project management experience and ability to influence cross-functional teams
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
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2026-01-07
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