Process Engineer for manufacturing OT (hybrid)

As the SpiraTec Group, we are the experts when it comes to industrial planning and high-tech solutions in the areas of digital transformation, engineering, robotics services, automation and IT in the industrial environment, together with over 650 employees in Germany, France, Italy, Austria, Switzerland and the USA at more than 40 locations. Become part of the SpiraTec success story and actively contribute to the establishment of our team at our Raleigh location. We are seeking a highly motivated Process Engineer to join our team for Operational Technology (OT) in manufacturing. In this hybrid position, you will work with our local and international team to deliver top-quality projects to our customers in the Pharmaceutical Manufacturing environment.

What are your responsibilities

• Collaborate with existing and new clients to understand their requirements and support the implementation of Industrial OT (such as MES, PIMS, and Historian systems) activities and support services to meet their needs
• In an agile environment, you support the implementation of projects on time and within budget, and yo support the design, development, installation, and commission of industrial IT/OT solutions including after-market support
• You support the implmentation of technologies for Industrial IT and advise on the qualification and validation of pharmaceutical equipment and computer systems according to current quality standards such as 21 CFR Part 11 and GAMP5
• In systems of production-related OT (MES/MOM) you map productions processes and apply relevant industrial standards (ISA95, OPC UAS, etc.)
• Act as the primary point of contact for clients and stakeholders and manage client relationships effectively and participate in the development of proposals and presentations to potential clients
• You support to ensure compliance with quality standards, prepare workshops/training sessions and collaborate on the creation of system and qualification documentation

What we appreciate about you

Required Skills

• You have an academic degree in Computer Science, Engineering, or other sciences
• You have experience in manufacturing OT consulting and implementation, with a focus on the pharmaceutical industry
• You are a team player who enjoys working in a dynamic project environment and have experience in software engineering and with production-related IT/OT solutions
• knowledge of GxP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
• Some travel is required for Customer site

Desired Skills

• Experience in process consulting/optimization and requirements engineering as well as in vertical MES integration (ERP, automation, LIMS, logistics) is an advantage
• Experience in Werum PAS-X MES, Emerson Syncade, Siemens OPCENTER or Aveva PI systems is a plus