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. We offer great benefits, and exciting challenges for both career and personal leadership development.
Company Culture Guidelines & Values:
- We are Professional.
- We are Trustworthy and have Integrity.
- We Communicate.
- We are a Team.
- We pursue Excellence.
- We are Safe.
Hughes Consulting is hiring for a Process Engineer to support cradle-to-grave engineering and capital projects within the Pharmaceutical Industry located in or near Virginia. 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.
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)
- Minimum 5 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
Desired Skills/Experience:
- Automated Visual Inspection (AVI)
- Project Management
- CQV (Commissioning, Qualification & Validation)
Why Hughes Consulting?
- High growth potential and fast paced organization with a people focused culture
- Competitive pay plus performance-based incentive programs
- Company paid Medical premiums for Employee option.
- Dental & Vision insurances
- Company paid Life, Short-Term, and Long-Term Disability insurances
- Health Savings Account
- 401(k) Retirement Plan (employer contribution)
- Paid Time Off (rollover option) and Paid and Floating Holidays
- Paid Parental Leave
- Leadership development training, career planning, and tuition reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Engaged and experienced Leadership Team
Hughes Consulting was established 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 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 or follow us on LinkedIn.
*Hughes Consulting is an equal opportunity employer, and we are not accepting recruiting agency support.*