Process Engineer for manufacturing OT (hybrid)

SpiraTec AG; Raleigh (NC); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

On-the-job training

Individual employee support

Team-oriented work culture

Job summary

SpiraTec AG, based in the United States, is seeking a Senior Process Engineer to join their Operational Technology team. This hybrid role involves collaborating with clients to deliver innovative solutions in the Pharmaceutical Manufacturing sector, leveraging your expertise in Industrial OT.

The ideal candidate holds a degree in Computer Science or Engineering and has substantial experience in manufacturing OT, with knowledge in GxP standards.

Qualifications

• Academic degree in Computer Science, Engineering, or other sciences required.
• Experience in manufacturing OT consulting and implementation, especially in pharmaceuticals.
• Team player in a dynamic project environment with software engineering experience.

Responsibilities

• Collaborate with clients to implement Industrial OT activities.
• Support project implementation on time and within budget.
• Advise on qualification and validation of pharmaceutical equipment.

Skills

Manufacturing OT consulting

GxP manufacturing knowledge

Software engineering

Team collaboration

Education

Degree in Computer Science, Engineering, or related field

Tools

Werum PAS‑X MES

Emerson Syncade

Siemens OPCENTER

Aveva PI systems

Job description

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 Bay Area (Vacaville), California location. We are seeking a highly motivated Senior 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.

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 you support the design, development, installation, and commission of industrial IT/OT solutions including after‑market support.
• You support the implementation 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 production 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.

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.

Benefits

• Be part of a future‑oriented company and implement innovative solutions with us based on the latest technologies and approaches (digitalization, Industry 4.0).
• We support our employees individually through training and offer the opportunity to develop into a leadership role.
• SpiraTec is characterized by a team‑oriented work culture, flat hierarchies, short decision‑making processes and an open communication culture.
• We are offering on‑the‑job training, providing you with hands‑on experience and the opportunity to work with experienced engineers and consultants.
• With us, you will find an agile onboarding and a personal buddy during your orientation period.

All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Applicants must be authorized to work in the United States at the time of application. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Apply quickly and easily via our online application form.