Manager of Process Engineering - Onsite - Marlborough, MA

As the Manager of Process Engineering, you will be responsible for defining and implementing the industrial and infrastructure resources needed for manufacturing, according to the quality, costs, schedule, and compliance goals.

What you will accomplish together with us:

• Lead the engineering activities, setting clear goals and priorities aligned with the company's operational objectives and long-term growth plans. Develop and implement strategic initiatives for the engineering department, ensuring alignment with GMP and regulatory requirements.
• Oversee new equipment and systems' design, installation, and qualification, including bioreactors, chromatography, filling lines, and HVAC systems. Ensure that all systems meet GMP standards and support manufacturing operations efficiently.
• Ensure all engineering projects and systems meet GMP requirements and are validated according to regulatory guidelines (e.g., FDA, EMA). Oversee and perform equipment qualification (IQ/OQ/PQ) and facility validation activities, ensuring proper documentation and compliance.
• Manage capital projects from concept through completion, including budgeting, timelines, resource allocation, and contractor management. Lead projects for equipment installations in support of client needs.
• Develop and implement preventive and predictive maintenance programs to ensure equipment reliability and minimize downtime. Ensure timely maintenance of critical manufacturing equipment and utilities such as clean steam, purified water, and HVAC systems.
• Identify opportunities to improve manufacturing processes through engineering solutions. Collaborate with the operations, quality, and automation teams to optimize throughput, reduce waste, and enhance process reliability.
• Lead and mentor a team of engineers and technicians, fostering a culture of collaboration, innovation, and continuous learning. Provide technical guidance and support for troubleshooting equipment and process issues.
• Work with facility management to ensure the operation, maintenance, and optimization of critical utilities, including purified water systems, clean steam generation, HVAC systems, and waste management, comply with regulatory and environmental standards.
• Manage the engineering budget, including capital expenditures, operational expenses, and cost control measures. Identify and justify capital investment opportunities for equipment and facility upgrades.
• Manage relationships with external vendors, contractors, and service providers to ensure timely project execution, procurement of high-quality equipment, and adherence to budget and timeline constraints.

What will convince us:

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, or similar) or a related field
• 7+ years of engineering experience within a biotech, pharmaceutical, or CDMO environment, with at least 3+ years in a leadership role
• Strong understanding of GMP, FDA regulations, and other applicable regulatory guidelines
• Proven experience in process engineering, equipment design, project management, and change control in a regulated environment for novel therapeutics, including cell and gene therapy
• Knowledge of validation protocol (IQ, OQ, PQ) and equipment qualification.
• Familiarity with bioprocessing equipment (e.g., bioreactors, chromatography systems) and cleanroom operations
• Experience with facility and utility management, including HVAC, clean steam, and water systems in a GMP environment

We value:

• An advanced degree or professional engineering certification (e.g., PE)
• Strong knowledge of engineering systems, processes, and utilities in a biotech manufacturing environment
• Ability to quickly ramp up activity with minimal resources and guidance
• Proven ability to troubleshoot and resolve complex engineering challenges in a manufacturing setting
• Ability to lead and mentor a team of engineers, fostering growth and promoting a high-performance culture
• Skilled at managing multiple projects, ensuring completion within budget and timeline while maintaining quality standards
• Deep understanding of GMP requirements, regulatory compliance, and validation procedures in biotech/pharma settings
• Identification with our core values: Sustainability, Openness, Enjoyment

What We Offer

As a growing global life science company, with our stock listed on the German DAX and TecDAX , Sartorius offers a wide range of benefits:
Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as "Coaching", "Agile Working" and a "Businesswomen's Network"
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.

Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women's Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability or based on status in any other protected group of class.

Please view equal employment opportunity posters provided by OFCCP here.

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Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.

We look forward to receiving your application.

www.sartorius.com/career

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at accommodationrequest@sartorius.com

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, or disability, or based on status in any other protected group of class.

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening. You can request reasonable accommodation by e-mail at accommodationrequest@sartorius.com

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers