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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. As a fast learner, you will have the opportunity to grow your skills and knowledge in the field of pharmaceutical IT/OT engineering.

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

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

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.

Would you like to become part of the team?

Apply quickly and easily via our online application form.