Project Manager for manufacturing OT (hybrid/remote)

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

Job summary

SpiraTec Solutions Inc. seeks a motivated Project Manager for Operational Technology in our Raleigh, NC area. You will lead OT projects in pharmaceutical manufacturing, building client relationships and delivering IT/OT solutions with after-market support.

You’ll work with global teams to implement MES/MOM integrations and ensure GxP/GAMP5 compliance. The role requires experience in OT/MES environments, strong communication skills, and willingness to travel to customer sites.

Qualifications

• Experience in the OT environment (MES) in Pharmaceutical, Biotech, or Life Sciences industries.
• First project management experience is a plus.
• Team-oriented in a dynamic project environment with ability to work independently.
• Strong technical writing and presentation skills; willingness to travel to customer sites.

Responsibilities

• Manage industrial OT projects in manufacturing for Pharma/Biotech/Life Sciences customers.
• Develop and maintain client relationships; identify and win new business.
• Plan, implement, and commission IT/OT solutions and provide after-market support.
• Advise on installation and qualification of equipment and computer systems per GxP and GAMP5.
• Map production processes in MES/MOM and align with ISA95, OPC UA standards.
• Implement MES/MOM integrations with ERP (L4) or shop-floor (L2) systems.

Skills

OT experience

MES experience

Team player

Independent worker

Technical writing

Travel ready

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, nad North Carolina, we support comanies in the (bio)pharmaceutical, chemical, and petrochemical industries in the digital transformation of their production processes. As part of al global company, we combine international engineering expertise with local implementation skills - creating ideal conditions for your personal developement in an innovative enviroment.

Become part of the SpiraTec success story and actively contribute to the establishment of our team at Raleigh, North Carolina location. We are seeking a highly motivated Project Manager to join our team for Operational Technology (OT) in manufacturing. In this hybrid postion, 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

• You are responsible for the project management of industrial OT projects in the manufacturing environment for customers in the Pharmaceutical, Biotech, or Life Sciences industries.
• You develop and maintain current client relationships as well as identify and acquire new potential clients.
• You implement projects and design, develop, installs and commission industrial IT solutions including after-market support.
• You are responsible for the implementation of technologies for digitalization and IT/OT and advise on the installation and qualification of pharmaceutical equipment and computer systems according to GxP and GAMP5.
• In systems of production-related IT/OT (MES/MOM) you map production processes and apply relevant industrial standards (ISA95, OPC UA, etc.).
• You implement production management systems (MES/MOM) for our customers and support their integration into enterprise resource planning systems (L4) or shop floor systems (L2).

What we appriciate about you

Required Skills

• You have solid experience in the OT environment (MES) in Pharmaceutical, Biotech, or Life Sciences industries, ideally with first project management experience.
• You are a team player who enjoys working in a dynamic project environment and have experience in software engineering and with production-related IT solutions.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in technical writing and presentation skills.
• Some travel is required for Customer site visit.

Desired Skills

• Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards.
• Knowledge in process consulting/optimization and requirements engineering as well as in vertical MES integration (ERP, automation, LIMS, logistics) is an advantage.
• Working knowledge of GxP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.

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.
• 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.