Principal Process Engineer - Aseptic Fill & Finish

Description

• Process Development & Transfer: Leading tech transfers, optimizing processes, and developing Master Batch Records (MBRs) and SOPs.
• Contributing to proposal development
• Presenting multiple times per year at industry conferences or networking events
• Training & Leadership: Developing and delivering technical training, acting as a technical lead, and providing expert support.
• 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
• Interfaces with OEM’s/vendors as needed to accomplish equipment sizing and selection.
• Quality & Contamination Control: Overseeing environmental monitoring, media fills, gowning, cleaning, and root cause analysis for contamination events.
• Authoring publications and white papers
• Participating in DG capabilities presentations to clients
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
• 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.

Requirements

• Experience in proposal generation and supporting business development.
• Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
• 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.
• Experience with FDA and EMA regulatory standards.
• Aseptic Processing: Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
• Technology & Equipment: Mastery of isolators, RABS, VHP decontamination, peristaltic/piston pumps, visual inspection.
• Working knowledge of process definition means and methods including identifying process unit operations required
• Minimum of 20 years of pharmaceutical and biologics process system engineering/design experience.
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
• Front-end/feasibility study experience.
• 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.
• BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance