Process Engineer - Manufacturing OT (Hybrid)

About the role

SpiraTec Solutions Inc., part of the SpiraTec Group, is the specialist for automation and IT solutions in the process industry in North America, supporting (bio)pharmaceutical, chemical and petrochemical companies in the digital transformation of their production processes. It is looking for a Process Engineer for manufacturing OT (hybrid) in Raleigh.

Key responsibilities

• Work with existing and new clients to understand their needs and support the implementation of Industrial OT (MES, PIMS, Historian systems) and related support services.
• In an agile environment, help deliver projects on time and within budget, and support the design, development, installation and commissioning of industrial IT/OT solutions, including after-market support.
• Advise on the qualification and validation of pharmaceutical equipment and computer systems according to quality standards such as 21 CFR Part 11 and GAMP5.
• In production OT systems (MES/MOM), map production processes and apply industrial standards such as ISA95 and OPC UA.
• Act as the main contact for clients and stakeholders, manage client relationships, and take part in developing proposals and presentations.
• Help ensure compliance with quality standards, run workshops and training sessions, and contribute to system and qualification documentation.

Required profile

• A degree in Computer Science, Engineering or another science.
• Experience in manufacturing OT consulting and implementation, with a focus on the pharmaceutical industry.
• Team player who enjoys a dynamic project environment, with experience in software engineering and production-related IT/OT solutions.
• Knowledge of GxP manufacturing and regulatory requirements for biologics and pharmaceuticals.
• Some travel to customer sites is required.

Required skills

• Desired: process consulting, optimization and requirements engineering, and vertical MES integration (ERP, automation, LIMS, logistics).
• Desired: experience with Werum PAS-X MES, Emerson Syncade, Siemens OPCENTER or Aveva PI systems.

What we offer

• Training and the chance to develop into a leadership role.
• On-the-job training with experienced engineers and consultants.
• Agile onboarding with a personal buddy during orientation.
• A team-oriented culture with flat hierarchies and short decision-making processes.