Hughes Consulting, A Salas O'Brien Company is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry.

Hughes Consulting, A Salas O'Brien Company is hiring for Process Engineers to support cradle-to-grave engineering and capital projects within the Pharmaceutical Industry. Typical projects include aseptic fill/finish/packaging, gene therapy, biotechnology (cell culture), facilities/utilities, and automation integration. We are seeking experienced Process Engineers that have specific experience in a cGMP or FDA regulated environment.

Applicants must be authorized to work for ANY employer in the U.S. without sponsorship now or in the future.

Process Engineer Responsibilities:

• Execute process, equipment, and facility changes in a cGMP environment.
• Provide technical support to Engineering Design, Construction Management, and CQV/Start-up teams as required for large facility projects.
• Collaborate with cross-functional teams (Engineering, MS&T, Operations, Quality, Maintenance, EHS, etc.) during the turnover, startup, and commissioning phases for facility, process, and utilities systems.
• Perform cycle development, engineering assessments, process improvements, data analysis, and troubleshooting.
• Support the investigation process, due diligence effort, and research corrections during incident investigations process and utility systems and advise on corrective actions.
• Support the development of project life-cycle documentation requirements as required for a cGMP compliant project (URS, change management, system specifications, drawings, change control, etc.)
• Evaluate existing processes, suggest measures for improvement, and configure manufacturing systems to reduce cost, improve sustainability, develop best practices, and boost productivity, quality, and profitability within the production process.
• Coordinate the selection and oversight of third-party engineering and design services.
• Work with startup teams during the turnover, startup and commissioning phases for process and utilities.

You will have:

• Bachelor’s Degree in Engineering (Chemical/Mechanical preferred)
• 1 to 10 years of relevant work experience supporting capital engineering projects within a pharmaceutical manufacturing, FDA or similar cGMP regulated environment
• Data integrity and Change Control experience
• Proficient computer skills
• Analytical skills
• Attention to detail
• Creative thinking and problem-solving skills
• Good verbal and written communication skills

Equal Opportunity Employment Statement

Salas O’Brien provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state/provincial, or local laws. Salas O’Brien will accommodate the disability-related needs of applicants as required by law.