Sr. Process Engineer - Visual InspectionPharmaceutical Manufacturing,Biotechnology Research
Hughes Engineering & Consulting is an exciting, fast growing company focused on process and project engineering and project management for the pharmaceutical industry. We offer great benefits and exciting challenges for both career development as well as professional leadership development for all employees.
**Hughes Engineering, PLLC is not accepting recruiting agency support. **
Hughes Engineering & Consulting is seeking a Senior Process Engineer to manage the design, fabrication, installation, startup, commissioning and qualification of Automated Visual Inspection machines as part of a major capital project. Candidates should have prior experience with cGMP capital projects; specifically, in the areas of Aseptic Formulation/Filling/Packaging. Equipment and Vendor management experience is important as well as specific experience with automated visual inspection of vials & syringes.
Senior Process Engineer Job Duties:
- Vendor management including project scope and vendor requirements for automatic inspection machines.
- Determines/Develops project specifications by studying product design, customer requirements and performance standards; completing technical studies; preparing cost estimates.
- Determine/develop together with other stakeholders the change scope and strategy to execute the change in a cGMP environment, process equipment, utilities, facility modification requirements to meet regulatory expectations and client quality standards for aseptic production environment.
- Controls project plan by reviewing design, specifications, and plan and schedule changes; recommending actions.
- Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
- Maintains project records and documentation such as meeting minutes, specifications (URS, FRS, etc.), drawings (P&ID, schematics), change control, etc.
- Bachelor’s Degree in Chemical or Mechanical Engineering
- High speed equipment design review, start up, commissioning and validation experience
- Minimum 8 years of relevant industry experience (SME level) to include automatic visual inspections (AVI)
- Experience with Seidenader AVI machines
- Aseptic Filling/manufacturing experience
Hughes Engineering & Consulting is a licensed engineering consulting company founded on individual leadership principles with over twenty-five years of experience serving the pharmaceutical industry. Our mission is to deliver best in class engineering services and project management without compromising our core leadership values. At Hughes Engineering & Consulting, we emphasize both personal and technical development for all associates through our leadership and technical training programs. For more information about our company, please visit www.hugheseng.com or follow us on LinkedIn.
**Hughes Engineering, PLLC is an equal opportunity employer.**