Manager of Process Engineering - Marlborough, MA - Inklusiver Job 🦼 🦻 🦯

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 :

We value :

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.

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

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 accommodationrequest@sartorius.com

Über Sartorius

Sartorius ist Teil der Lösung im Kampf gegen Krebs, Demenz und viele andere Krankheiten. Unsere Technologien helfen wissenschaftliche Erkenntnisse schneller in Medikamente für Patienten weltweit zu übersetzen.

Wir suchen ambitionierte Teamplayer und kreative Köpfe, die zu diesem Ziel beitragen und ihre Karriere in einem dynamischen globalen Umfeld vorantreiben wollen.

Werden auch Sie Teil der Lösung. Wir freuen uns auf Ihre Bewerbung.

www.sartorius.de / karriere

Gleiche Chancen für alle

Unterschiedliche Perspektiven und neue Ideen sind entscheidend, um Fortschritte in den Life Sciences und der Bioprozesstechnik zu vereinfachen, damit Menschen weltweit schneller Zugang zu neuen Therapien erhalten.

Als Arbeitgeber achten wir deshalb auf Chancengleichheit und stellen Menschen unterschiedlichster Herkunft, Geschlechtsidentitäten, Altersgruppen, körperlicher und geistiger Fähigkeiten, Bildungs- und Karrierewege und mehr ein. Dabei dulden wir keinerlei Diskriminierung von Bewerbenden und Mitarbeitenden.