Senior Process Engineer - Scale Up Facility

Senior Process Engineer - Scale Up Facility page is loaded## Senior Process Engineer - Scale Up Facilityremote type: Office Basedlocations: TAR Btime type: Full timeposted on: Posted Todayjob requisition id: R-25400Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.We are seeking a Senior Process Engineer to join our Scale Up Facility (SUF) team in Tarrytown, NY. This role provides technical leadership for scale-up and technology transfer activities in a regulated environment. You will own SUF infrastructure and equipment, lead complex engineering projects, mentor junior staff, and serve as a subject matter expert driving process optimization and compliance.**Key Responsibilities**## Leadership & Technical Expertise:* 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.## Infrastructure & Equipment Ownership:* 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.## Project Management & Continuous Improvement:* 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.**Qualifications*** Education: Bachelor’s degree in Engineering (Mechanical, Chemical) or related scientific discipline required; Master’s degree preferred.* Experience: 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 Skills*** 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.#LI-BH1**Who we are**: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.**How we work:** When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.To find out more about Siemens Healthineers businesses, please visit our company page .The base pay range for this position is:Min $119,910 - Max $179,870Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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.**Equal Employment Opportunity Statement:** Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.**EEO is the Law:** Applicants and employees are protected under Federal law from discrimination. To learn more, click .**Reasonable Accommodations:** Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form . If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [email protected]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.**California Privacy Notice:** California residents have the right to receive additional notices about their personal information. To learn more, click .**Export Control:** “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”**Data Privacy:** We care about your and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask #J-18808-Ljbffr