Project Manager - Manufacturing OT (Hybrid/Remote)

About the role

SpiraTec Solutions Inc., part of the SpiraTec Group, is the specialist for automation and IT solutions in the process industry in North America, supporting companies in the (bio)pharmaceutical, chemical and petrochemical industries in the digital transformation of their production processes. It is looking for a highly motivated Project Manager to join its Raleigh, North Carolina team for Operational Technology (OT) in manufacturing, working in a hybrid position with local and international colleagues to deliver projects to customers in the pharmaceutical manufacturing environment.

Key responsibilities

• Manage industrial OT projects in the manufacturing environment for customers in the pharmaceutical, biotech or life sciences industries.
• Develop and maintain existing client relationships and identify and acquire new potential clients.
• Implement projects and design, develop, install and commission industrial IT solutions, including after-market support.
• Advise on the installation and qualification of pharmaceutical equipment and computer systems according to GxP and GAMP5.
• In production-related IT/OT systems (MES/MOM), map production processes and apply industrial standards such as ISA95 and OPC UA.
• Implement production management systems (MES/MOM) for customers and support their integration into ERP (L4) or shop floor systems (L2).

Required profile

• Solid experience in the OT environment (MES) in pharmaceutical, biotech or life sciences industries, ideally with first project management experience.
• Experience in software engineering and with production-related IT solutions.
• Ability to work independently and collaboratively in a fast-paced environment.
• Some travel is required for customer site visits.
• Applicants must be authorized to work in the United States; visa sponsorship is not available.

Required skills

• Proficiency in technical writing and presentation skills.
• Desired: knowledge of ANSI/ISA-88 and ANSI/ISA-95 standards.
• Desired: process consulting, requirements engineering and vertical MES integration (ERP, automation, LIMS, logistics).
• Desired: working knowledge of GxP manufacturing and regulatory requirements for biologics and pharmaceuticals.

What we offer

• Training support and the chance to develop into a leadership role.
• A team-oriented culture with flat hierarchies, short decision-making processes and open communication.
• Agile onboarding with a personal buddy during orientation.