- Bachelor’s degree in mechanical, electrical, chemical, process, industrial, or a related engineering discipline.
- Experience working in pharmaceutical, biopharmaceutical, life sciences, or another GMP-regulated manufacturing environment.
- Experience managing engineering projects involving manufacturing equipment, utilities, facilities, or process systems.
- Prior experience supporting bioreactors, bioprocessing equipment, CIP systems, autoclaves, centrifuges or purified water systems
- Broad understanding of mechanical, electrical, process, and utility systems within an industrial manufacturing facility.
- Ability to review technical documentation, engineering drawings, equipment specifications, and system turnover information.
- Experience coordinating engineers, vendors, contractors, manufacturing teams, and other cross-functional stakeholders.
- Strong project ownership, organization, communication, and problem-solving skills.
- Ability to operate effectively in a greenfield, startup, or rapidly changing manufacturing environment.
Preferred Qualifications
- Experience with facility startup, construction turnover, commissioning, qualification, validation, or operational readiness.
- Experience with clean utilities or plant utilities, including purified water, steam, compressed air, boilers, chillers, pumps, or distribution systems.
- Familiarity with production equipment ownership and maintenance program development.
- Experience working across both GMP and non-GMP systems.
- Familiarity with SAP or another computerized maintenance management system.
- Previous experience in pharmaceutical manufacturing, nuclear power, advanced manufacturing, chemical processing, or another highly regulated industrial environment.
- Ability to translate technical needs into clear scopes, project plans, and executable work packages.
Position Overview
We are seeking a versatile Mechanical/Project Engineer to join the engineering organization supporting the startup of a large-scale greenfield pharmaceutical manufacturing facility in Raleigh-Durham, North Carolina. This individual will manage multidisciplinary engineering projects across manufacturing equipment, clean and plant utilities, mechanical systems, electrical infrastructure, and process systems. Because the site is in an early phase of development and operational readiness, the engineer must be comfortable working in an evolving environment where priorities may shift between construction turnover, equipment readiness, utility systems, production needs, and general site engineering activities. The ideal candidate will bring pharmaceutical, biopharmaceutical, or other regulated GMP manufacturing experience and possess a broad technical foundation rather than expertise in only one engineering discipline. This role is well suited for someone who can evaluate technical problems, coordinate cross-functional stakeholders, manage projects from planning through completion, and take ownership of systems as the facility transitions toward operations.
Key Responsibilities:
- Manage engineering projects involving production equipment, process systems, utilities, mechanical infrastructure, and electrical systems.
- Coordinate project activities across engineering, manufacturing, maintenance, quality, automation, construction partners, equipment vendors, and other site stakeholders.
- Provide engineering oversight for equipment and systems such as: Bioreactors and bioprocessing equipment, Clean-in-place, or CIP, systems, Purified water and process water systems, Autoclaves, Centrifuges, Boilers and chillers, Plant utility and mechanical systems, Electrical equipment and distribution systems
- Review engineering drawings, equipment documentation, specifications, turnover packages, and system requirements.
- Identify technical gaps, project risks, constructability issues, and readiness concerns, then coordinate the appropriate path to resolution.
- Participate in equipment installation, startup, testing, turnover, and operational readiness activities.
- Develop project plans, define priorities, coordinate resources, and track work through completion.
- Coordinate technical decisions and project dependencies across multiple engineering disciplines.
- Facilitate issue resolution between internal stakeholders, contractors, equipment vendors, and construction partners.
- Confirm that engineering work and project documentation comply with site standards, GMP requirements, safety expectations, and applicable procedures.
- Help establish reliable engineering and maintenance practices as the site transitions from construction into startup and manufacturing operations.
- Provide engineering ownership for assigned systems and projects, which may shift between the production and utilities areas based on site priorities.
- Create and maintain clear project records, status updates, technical documentation, and action-item tracking.
- Contribute to the development of procedures, maintenance strategies, system ownership models, and long-term plant engineering standards.