Manager of Process Engineering - Marlborough, MA

As the Engineering Lead of Process Development Services at Sartorius, you will oversee the GMP engineering efforts and be responsible for managing the design, installation, qualification, validation, and maintenance of manufacturing equipment, systems, and facilities. This is a particularly of our importance in our change control strategies as we switch between new therapeutic modalities.

You will ensure compliance with regulatory standards while driving process improvements, equipment reliability, and operational efficiency in a GMP environment for Phase I Clinical Manufacturing. The ideal candidate will have extensive experience in biotech or pharmaceutical manufacturing, a deep understanding of engineering principles, and a proven ability to work with cross-functional teams.

What you will accomplish together with us:

• Engineering Leadership & Strategy: 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.
• Process & Equipment Design: Oversee the design, installation, and qualification of new equipment and systems, including bioreactors, chromatography, filling lines, and HVAC systems. Ensure that all systems are designed to meet GMP standards and support manufacturing operations efficiently.
• GMP Compliance & Validation: 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 throughout.
• Project Management: Manage capital projects from concept through completion, including budgeting, timelines, resource allocation, and contractor management. Lead projects for equipment installations in support client needs.
• Maintenance & Reliability Engineering: 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.
• Process Optimization & Continuous Improvement: 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.
• Team Leadership & Development: 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.
• Facility & Utility Management: 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 are compliant with regulatory and environmental standards.
• Budget Management: Manage the engineering budget, including capital expenditures, operational expenses, and cost control measures. Identify and justify capital investment opportunities for equipment and facility upgrades.
• Vendor & Contractor Management: 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. Advanced degree or professional engineering certification (e.g., PE) is a plus.
• 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, and 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.
• Excellent leadership and team management skills, with the ability to lead cross-functional projects.
• Strong problem-solving skills and technical expertise in engineering principles, automation, and manufacturing operations.

We value:

• Technical Expertise: Strong knowledge of engineering systems, processes, and utilities in a biotech manufacturing environment.
• Self-starter: Ability to quickly ramp-up activity with minimal resources and guidance
• Problem-Solving: Proven ability to troubleshoot and resolve complex engineering challenges in a manufacturing setting.
• Leadership: Ability to lead and mentor a team of engineers, fostering growth and promoting a high-performance culture.
• Project Management: Skilled at managing multiple projects, ensuring completion within budget and timeline while maintaining quality standards.
• Regulatory Compliance: 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, LinkedIn Learning, 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

All qualified applicants will be considered for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.

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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

Sartorius is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. 

All employment decisions are based on valid job-related requirements. 

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 calling +1 631 254 4249 ext 8330 or via e-mail at [email protected]
 

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