Process Engineer for manufacturing OT (hybrid)

Softgarden; Raleigh (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

SpiraTec Solutions Inc. in North America is seeking an experienced OT/IT consultant to support pharmaceutical manufacturing projects across MES/MOM and related systems.

In an agile, client-focused environment, you will understand requirements, map production processes, assist with qualification and validation per 21 CFR Part 11 and GAMP5, and contribute to proposals and presentations for potential clients. Travel to customer sites is expected.

Qualifications

• Academic degree in Computer Science, Engineering, or related sciences.
• Experience in manufacturing OT consulting and pharma manufacturing.
• Team player with experience in software engineering and production IT/OT.
• Knowledge of GxP manufacturing and regulatory requirements.
• Willingness to travel to customer sites.

Responsibilities

• Collaborate with clients to understand requirements and support OT/IT implementation.
• Assist projects in agile environments ensuring on-time, within-budget delivery.
• Support qualification and validation of pharmaceutical equipment per 21 CFR Part 11 and GAMP5.
• Map production processes in OT systems (MES/MOM) and apply standards.
• Serve as primary client contact and help develop proposals and presentations.
• Support quality compliance, workshops, and documentation creation.

Skills

OT consulting

Software engineering

Pharma regulatory knowledge

Team player

Travel willingness

Education

Bachelor's degree in Computer Science or Engineering

Tools

Werum PAS-X MES

Emerson Syncade

Siemens OPCENTER

Aveva PI

Job description

Within the SpiraTec Group, SpiraTec Solutions Inc. is the specialist for automation and IT solutions in the process industry in North America. With locations in California, Arizona, Ohio, and North Carolina, we support companies in the (bio)pharmaceutical, chemical, and petrochemical industries in the digital transformation of their production processes. As part of a global company, we combine international engineering expertise with local implementation skills—creating ideal conditions for your personal development in an innovative 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.

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 sponorship of an employment visa at this time.