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Engineering Consultant for Pharmaceutical Projects

2 months ago

Raleigh, North Carolina, United States Hughes Engineering, PLLC Full time

Job Type

Full-time

Position Overview

Hughes Engineering, PLLC is a dynamic and rapidly expanding firm dedicated to Process Engineering, Project Engineering, Project Management, and CQV solutions tailored for the pharmaceutical sector. We provide exceptional benefits and present stimulating challenges that foster both career and personal leadership growth.

Core Values & Company Culture:

  • Professionalism is paramount.
  • Integrity and Trustworthiness guide our actions.
  • Effective Communication is essential.
  • Teamwork is at the heart of our operations.
  • We strive for Excellence in all endeavors.
  • Safety is a priority.
Hughes Engineering, PLLC is currently seeking applications for Process Engineers to assist in comprehensive engineering and capital projects within the Pharmaceutical Industry. Typical projects encompass aseptic fill/finish/packaging, gene therapy, biotechnology (cell culture), facilities/utilities, and automation integration. We are looking for seasoned Process Engineers with specific expertise in a cGMP or FDA regulated environment.

Key Responsibilities:
  • Implement process, equipment, and facility modifications in a cGMP setting.
  • Offer technical assistance to Engineering Design, Construction Management, and CQV/Start-up teams as needed for large-scale facility projects.
  • Engage 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.
  • Conduct cycle development, engineering evaluations, process enhancements, data analysis, and troubleshooting.
  • Assist in the investigation process, due diligence efforts, and research corrections during incident investigations and utility systems, advising on corrective measures.
  • Support the creation of project life-cycle documentation necessary for a cGMP compliant project (URS, change management, system specifications, drawings, change control, etc.).
  • Assess existing processes, propose improvement strategies, and optimize manufacturing systems to lower costs, enhance sustainability, establish best practices, and increase productivity, quality, and profitability within the production process.
  • Oversee the selection and management of third-party engineering and design services.
  • Collaborate with startup teams during the turnover, startup, and commissioning phases for process and utilities.
Qualifications:
  • Bachelor's Degree in Engineering (Chemical/Mechanical preferred).
  • 2 to 4 years of relevant experience supporting capital engineering projects within a pharmaceutical manufacturing and/or FDA regulated environment.
  • Experience with data integrity and Change Control.
  • Proficient in computer applications.
  • Strong analytical capabilities.
  • Meticulous attention to detail.
  • Creative problem-solving skills.
  • Effective verbal and written communication abilities.
Preferred Skills:
  • Familiarity with Microsoft Project.
  • Experience with Aseptic Fill Lines.
Note: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Why Choose Hughes Engineering, PLLC?
  • High growth potential within a fast-paced organization that values its people.
  • Competitive compensation along with performance-based incentive programs.
  • Company-covered medical premiums for employee options.
  • Comprehensive dental and vision insurance.
  • Company-paid life, short-term, and long-term disability insurance.
  • Health Savings Account.
  • 401(k) Retirement Plan with employer contributions.
  • Generous Paid Time Off (with rollover option) and paid holidays.
  • Paid parental leave.
  • Opportunities for leadership development training, career planning, and tuition reimbursement.
  • Engaging team social activities.
  • Employee recognition programs.
  • Experienced and engaged leadership team.
Hughes Engineering, PLLC was founded on individual leadership principles with over twenty-five years of experience serving the pharmaceutical industry. Our mission is to deliver top-tier engineering services and project management while upholding our core leadership values. 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 our website or follow us on LinkedIn.

*Hughes Engineering, PLLC is an equal opportunity employer, and we are not accepting recruiting agency support.*