Head of Process Engineering Indianapolis - Controls

Roche•Indianapolis, IN

4d•Onsite

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Doing now what patients need next. The customer area Near Patient Care (NPC) unites Roche’s Point of Care and Diabetes Care portfolios. Our ambition is to improve disease management by enabling critical answers and personalized care, closer to the people we serve. With our passion we bring testing closer to patients and empower people to better monitor their own health and help healthcare professionals make faster, more confident decisions closer to the patient. Within NPC Operations, we are globally accountable for the end-to-end production of solutions for continuous glucose monitoring (CGM), blood glucose monitoring (BGM), and insulin delivery (IDS), as well as Point-of-Care (POC) products. The most relevant internal manufacturing sites are Mannheim in Germany and Indianapolis in the USA. Your New Team As Manufacturing Science and Technology in NPC Operations, we bridge the gap between development and manufacturing. With around 200 colleagues across Mannheim, Indianapolis, and Rotkreuz, we lead technology strategy, product design industrialization, and collaboration with external partners throughout the product lifecycle. As a project-based organization, we enable scalable product designs ready for mass production, ensure robust processes and equipment for excellent yields, and ensure scalable QC processes. Partnering with external networks, we secure competitive manufacturing costs and reliable production. We are committed to building a global, inclusive team, bringing together various perspectives and skills to foster innovation and create a great place to work for all. Your New Role As the Head of Process Engineering - Controls (m/f/d), you will lead a local high-performing team of automation and electrical engineers and shape an inclusive work environment that drives digital innovation through global collaboration and diverse perspectives. In this central position, you and your team will be responsible for the automation strategy and the electrical design for our complex special-purpose machines for the assembly of medical devices. Your focus will be on translating innovative R&D concepts into intelligent, networked, and mass-production-ready processes.

Requirements

Bachelor's, Master's, or PhD in a relevant engineering or natural science degree program.
5+ years of professional experience in a relevant engineering function.
2+ years of proven experience as a matrix leader or ideally as a direct supervisor.
Verifiable practical experience with GAMP 5, Computer System Validation (CSV), and data integrity (21 CFR Part 11) in the regulated medical technology or pharmaceutical environment.
Routine handling of international guidelines for electrical equipment safety (e.g., Machinery Directive, CE, UL/CSA for the US market).
Routine in creating requirement specifications, managing, and accepting external automation and software work packages.
Ability to build bridges in a global, project-oriented environment and position the automation discipline as a central enabler between R&D and production.
Excellent communication skills to mediate between classic engineering (mechanics), IT infrastructure, and management and to make technical visions tangible.
Strong affinity for Industry 4.0, IoT, and data-driven manufacturing, as well as a solution-oriented "hands-on" mentality.

Responsibilities

Leadership and strategic development of a team of automation, software, and electrical engineers.
Fostering a diverse and inclusive team culture that drives digital and electrotechnical innovation.
Definition and global implementation of the automation strategy (hardware, software, control technology) for highly complex medical device assembly systems.
Translating product designs into smart, automated processes.
Responsibility for the seamless integration of sensor technology, actuator technology, and control technology to scale systems for mass production.
Management and partnership-based collaboration with external automation service providers, control cabinet manufacturers, and software suppliers (including acceptance of code, electrical designs, and support for FAT/SAT).
Ensuring compliance with regulatory requirements for medical technology with a focus on automation (e.g., GAMP 5, 21 CFR Part 11, machine safety/CE/UL) and responsibility for Computer System Validation (CSV).
Development and integration of inline quality controls (e.g., vision systems) and ensuring smooth data acquisition and connection to higher-level systems (MES, ERP, SCADA) for efficiency improvement and cost optimization.
Close coordination with Process Science, Process Engineering, IT, Quality Assurance, and Production to guarantee a perfect symbiosis of mechanics, electrics, and software.
Continuous identification and implementation of market trends (e.g., AI-supported error detection, Smart Sensors, Advanced Robotics) to actively drive the digitalization of the production landscape.