Process Engineer for manufacturing OT (hybrid)

SpiraTec AG

$80K — $110K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Academic degree in Computer Science, Engineering, or other sciences required.
  • Experience in manufacturing OT consulting and implementation, specifically in the pharmaceutical industry.
  • Familiarity with GxP manufacturing and regulatory standards for biologics/pharmaceuticals.
  • Team-oriented, with demonstrated ability in dynamic project environments and software engineering.
  • Willingness to travel for customer site visits as needed.

Responsibilities

  • Collaborate with clients to understand requirements and support the implementation of Industrial OT activities.
  • Support project implementations, ensuring they are completed on time and within budget.
  • Design, develop, install, and commission industrial IT/OT solutions, including providing after-market support.
  • Advise on qualification and validation of pharmaceutical equipment and computer systems according to quality standards like 21 CFR Part 11.
  • Map production processes and apply industrial standards in production-related OT systems.
  • Manage client relationships and participate in proposal and presentation development.
  • Ensure compliance with quality standards and support the creation of system and qualification documentation.

Benefits

  • Innovative work with cutting-edge technologies related to digitalization and Industry 4.0.
  • Individual training opportunities and the chance to grow into a leadership role.
  • Team-oriented culture with flat hierarchies and open communication.
  • On-the-job training providing hands-on experience with seasoned professionals.
  • Agile onboarding process with personal buddy support during orientation.
Full Job Description
Process Engineer for manufacturing OT (hybrid) We are seeking a highly motivated 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 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 yo support the design, development, installation, and commission of industrial IT/OT solutions including after-market support - You support the implmentation 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 productions 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 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 Would you like to become part of the team? Apply quickly and easily via our online application form.

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