Senior Process Engineer for manufacturing OT (hybrid/remote)

SpiraTec Group; Vacaville (CA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Training opportunities

Agile onboarding

Leadership development

Job summary

A technology solutions provider is seeking a Senior Process Engineer for its Bay Area location in Vacaville, California. This hybrid position involves collaborating with clients on Operational Technology in pharmaceutical manufacturing, ensuring project implementation within budget and timeframe, and advising on compliance with quality standards. Candidates should possess a degree in Computer Science or Engineering and have experience in manufacturing OT. Opportunities for training and professional growth are available.

Qualifications

• Academic degree in Computer Science, Engineering, or related fields.
• Experience in manufacturing OT consulting and implementation.
• Knowledge of GxP regulations in the pharmaceutical industry.

Responsibilities

• Collaborate with clients to provide Industrial OT implementation services.
• Design, develop, install, and commission industrial IT/OT solutions.
• Act as primary point of contact for clients and manage relationships.

Skills

Manufacturing OT consulting

Software engineering

Team player

Knowledge of GxP regulations

Education

Degree in Computer Science, Engineering, or related

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.

What are your responsibilities

• Collaborate with existing and new clients to understand their requirements and provide Industrial OT (such as MES, PIMS, and Historian systems) implementation and support services to meet their needs.
• In an agile environment, you implement projects on time and within budget, and you design, develop, install, and commission industrial IT/OT solutions including after-market support.
• You are responsible for 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 UA, 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 will ensure compliance with quality standards, conduct 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

What awaits you at SpiraTec

• 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.