At iBio, we’re enabling the next generation of biologics with the FastPharming® System for high-quality, eco-friendly recombinant protein production. We’re putting these capabilities to work for our clients via our array of contract development and manufacturing services, as well as deploying them for the advancement of our own pipeline of therapeutics, vaccines, and products for research & bioprocessing applications. We accomplish all of this via our CGMP 130,000 square foot facility in Bryan, TX.
Just imagine what we can do together! We know great things happen when talent and opportunity cross paths. We are looking to hire exceptional people who have demonstrated track records of success. Our greatest scientific solution is bringing talented people together who have a passion for advancing plant-based biologics for our customers and the world.
Apply now for our Project Engineer position and help bring the power of plants to the biopharmaceutical industry!
Mission of the Position
The Project Engineer is responsible for improving work force productivity and quality by anticipating and eliminating potential delays through planning, CMMS software utilization, scheduling, and coordination of maintenance/calibration resources, parts, materials, and equipment access.
This position will plan projects and establish the criteria by which project success will be measured. The project engineer will be required to establish project inspection criteria, coordinate the review of project designs, and ensure the proper implementation of project elements. Additionally, the position will be responsible for scheduling, planning, forecasting, resource management, and all technical activities, assuring project accuracy and quality from conception to completion.
The Project Engineer position is located in Bryan, Texas.
Essential Duties & Responsibilities
- Prepare, schedule, coordinate and monitor all assigned engineering projects
- Monitor compliance to applicable codes, practices, safety policies, QA/QC policies, performance standards and specifications
- Perform overall quality control of the work (budget, schedule, plans, contractor’s performance) and report regularly on project status
- Review engineering deliverables and initiate appropriate corrective actions
- Develop the specifications for all equipment that are required for each project
- Oversee the design, implementation and commissioning of key projects
- Maintain upkeep of CMMS asset information, SOPs, and work records
- Act as in-house expert on the CMMS and provide training to Facilities personnel on asset management and equipment release
- Establish and maintain calibration, maintenance, and validation schedules, events, and work records for all GxP process systems and equipment
- Lead asset management forum across entire organization (GMP and non-GMP).
- Execution of all workflows within the scope of Facilities/Engineering/Validation
- Triage of change/work requests for on-demand activities or updates to the CMMS
- Support generation of site KPIs and metrics reports
Knowledge, Skills, & Abilities
- Ability to make decisions under time constraints
- Demonstrated proficiency using Microsoft Suite
- High level of knowledge using design and visualization software such as AutoCAD
- Ability to work in an office environment as well as in the field as requested
- Ability to analyze and trend data via statistical analysis to predict equipment performance
- Ability to collaborate with different functional groups and prioritize organizational needs
Education & Experience
- Bachelor of Science degree in Chemical or Mechanical Engineering
- 2-3 years of experience working as an engineer in an FDA regulated facility preferred
- 3-5 years of Manufacturing Experience; preferably in the manufacture of pharmaceuticals
- Prior experience in construction or relative field preferred
- Experience working in FDA regulated environment is preferred