About the Position

Join SpiraTec AG as a Process Engineer for manufacturing OT (hybrid) in Raleigh, North Carolina, USA. Collaborate with clients to implement Industrial OT activities and support services.

Responsibilities

Collaborate with existing and new clients to understand their requirements and support the implementation of Industrial OT activities and support services.
Support the implementation of projects on time and within budget.
Design, develop, install, and commission industrial IT/OT solutions including after-market support.
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.
Map production processes and apply relevant industrial standards (ISA95, OPC UAS, etc.) in systems of production-related OT (MES/MOM).
Act as the primary point of contact for clients and stakeholders and manage client relationships effectively.
Participate in the development of proposals and presentations to potential clients.
Ensure compliance with quality standards, prepare workshops/training sessions, and collaborate on the creation of system and qualification documentation.

Requirements

Academic degree in Computer Science, Engineering, or other sciences.
Experience in manufacturing OT consulting and implementation, with a focus on the pharmaceutical industry.
Experience in software engineering and with production-related IT/OT solutions.
Knowledge of GxP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.
Team player who enjoys working in a dynamic project environment.
Some travel is required for customer site.

Nice to Have

Experience in process consulting/optimization and requirements engineering.
Experience in vertical MES integration (ERP, automation, LIMS, logistics).
Experience in Werum PAS-X MES, Emerson Syncade, Siemens OPCENTER, or Aveva PI systems.

We Offer

Be part of a future-oriented company and implement innovative solutions with us based on the latest technologies and approaches (digitalization, Industry 4.0).
Individual support through training and the opportunity to develop into a leadership role.
Team-oriented work culture, flat hierarchies, short decision-making processes, and an open communication culture.
On-the-job training, hands-on experience, and the opportunity to work with experienced engineers and consultants.
Agile onboarding and a personal buddy during your orientation period.

About the Company

Within the SpiraTec Group, SpiraTec Solutions Inc. is the specialist for automation and IT solutions in the process industry in North America. With locations in California, Arizona, Ohio, and North Carolina, we support companies in the (bio)pharmaceutical, chemical, and petrochemical industries in the digital transformation of their production processes. As part of a global company, we combine international engineering expertise with local implementation skills-creating ideal conditions for your personal development in an innovative environment.

Application

Would you like to become part of the team? Apply quickly and easily via our online application form.

Contact person: Nicole Jurke

Coordinator People & Culture

Tel: +49 6232 91906-220

Process Engineer for manufacturing OT (hybrid)

Job description