Principal Process Engineer – API + OSD

Principal Process Engineer

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.

The Principal Process Engineer role is a key member of the Life Science Commercial Team with responsibilities beginning with initial client contact, developing early stakeholder (client) alignment based on relationships built on technical competency, proactive client engagement and development of innovative solution. Principal will 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.

In addition to working on front end phases, you will be expected and responsible for performing technical business development active, which would include:

• Participating in DG capabilities presentations to clients
• Contributing to proposal development
• Authoring publications and white papers
• Presenting multiple times per year at industry conferences or networking events

Responsible 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.

Passionate industry expert with outgoing personality that has experience presenting innovative concepts to other thought leaders, possessing the ability to generate interest, facilitate adoption, and create advocacy for emerging concepts while being cognizant of disruptive technologies and trends that influence investment decisions.

• cGMP & Regulatory Compliance:
  Deep understanding of FDA/EMA guidelines (like USP , Annex
  1) and managing inspections/deviations.
• API Process Development & Engineering:
• Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial-scale manufacturing
• Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
• Establish process parameters, control strategies, and manufacturing specifications for API production
• OSD Process Development & Engineering:
• Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial-scale manufacturing
• Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
• Establish process parameters, control strategies, and manufacturing specifications for API production
• Process Development & Transfer:
  Leading tech transfers, optimizing processes, and developing Master Batch Records (MBRs) and SOPs.
• Quality & Contamination Control:
  Overseeing environmental monitoring, media fills, gowning, cleaning, and root cause analysis for contamination events.
• Training & Leadership:
  Developing and delivering technical training, acting as a technical lead, and providing expert support.

Executes 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. Works closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation to ensure systems are designed in accordance with current Good Manufacturing Practices. Understanding and development of process construction documents including piping & instrument diagrams (P&IDs), equipment general arrangement drawings, piping plans inclusive of orthographic and isometric drawings, operator access platform and equipment support drawings, line lists, tie-in lists, installation specifications, bills of material (BOM), scopes of work, etc.

Interfaces with OEM's/vendors as needed to accomplish equipment sizing and selection. Develops project scopes and assists with preparation of proposals for engineering/design services as well as complete constructed solutions. Stays abreast of new and emerging technologies, and current Good Manufacturing Practices. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.

What You'll Bring

• 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),…