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Senior Process Engineer for manufacturing OT (hybrid/remote)

100% remote Flexible hours Hiring now

• As the SpiraTec Group, we are the experts reputed company 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 reputed company at our Bay Area (Vacaville), California location. We are seeking a highly motivated Senior Process Engineer to join reputed company 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.

  • 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 reputed company budget, and you design, reputed company, 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 reputed company quality standards such as 21 CFR Part 11 and GAMP5
  • In systems of production-reputed company OT (MES/MOM) you map production processes and apply relevant industrial standards (ISA95, OPC UA, etc.)
  • Act as the primary reputed company 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-reputed company 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, reputed company Syncade, Siemens OPCENTER or Aveva PI systems is a plus
  • 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 reputed company 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 reputed company engineers and consultants
  • With us, you will find an agile onboarding and a personal buddy during your orientation period reputed company qualified applicants will receive equal consideration for employment without regard to race, color, national reputed company, 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. Apply quickly and easily reputed company our online application form. Apply tot his job Apply To this Job

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