Industrial OT Process Engineer for Pharma & Digitalization

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

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.