Principal Process Engineer – API + OSD

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

What You’ll Do

• Work with a team of industry experts to help the world’s leading companies solve their most difficult problems.
• Lead front end design programming for API and/or OSD processes requiring site survey, space programming and equipment evaluation/selection, economic analysis/justification, risk assessments, and regulatory impact reviews.
• Perform technical business development actively, including participating in DG capabilities presentations to clients, contributing to proposal development, authoring publications and white papers, and presenting multiple times per year at industry conferences or networking events.
• Lead as leading expert for Active Pharmaceutical Ingredients (APIs) and/or Oral Solid Dose (OSD) processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, recognized industry expert through published/presented thought leadership, and for launching and nurturing lifecycle client programs.
• Develop and deliver technical training, act as a technical lead, and provide expert support.
• Execute process system engineering from conceptual/planning to final/detail design phase on a wide range of projects from system enhancements or unit operation optimization through all-new greenfield construction.
• Work closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation to ensure systems are designed in accordance with current Good Manufacturing Practices.
• Develop project scopes and assist with preparation of proposals for engineering/design services as well as complete constructed solutions.
• Stay abreast of new and emerging technologies, and current Good Manufacturing Practices.

What You’ll Bring

• A minimum of 20 years of pharmaceutical and biologics process system engineering/design experience.
• Experience in proposal generation and supporting business development.
• Front-end/feasibility study experience.
• Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
• Working knowledge of process definition means and methods including identifying process unit operations required.
• Experience with FDA and EMA regulatory standards.
• Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients.
• Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic).
• Familiarity with 3D modeling, computer-based hydraulic analysis and process simulation software skills are considered a plus.
• Willing and able to travel as necessary for project requirements to include but not limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

Qualifications

• BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.

Pay Range

The approximate pay range for this position is $170K - $240K. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.