Principal, Process Engineer - Biologics

Overview

When you join Design Group as a Principal Process Engineer, you are joining a team that will challenge you and position you for growth. You will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Architecture/Engineering Process Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver high quality solutions to our clients with consistency and accuracy.

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 alignment based on relationships built on technical competency, proactive client engagement and development of innovative solutions. The role will lead front end design programming for Biologics processes requiring site survey, space programming and equipment evaluation/selection, economic analysis/justification, risk assessments, and regulatory impact reviews.

In addition to front end phases, you will be expected to perform active technical business development, 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

Responsibilities include leading expert roles for Biologics processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier partnerships, recognized industry thought leadership, and launching and nurturing lifecycle client programs. You will define concepts, generate client engagement/alignment, evaluate existing processes/operations, define scale/modality appropriate solutions, align integration approach, and provide the qualification strategy for both traditional processing methods and emerging technologies to align with regulatory guidance.

You will also:

• Develop process operations concepts and client engagement strategies
• Demonstrate a passion for industry topics, presenting innovative concepts to thought leaders and driving adoption while considering disruptive technologies and trends
• Maintain deep understanding of cGMP and regulatory compliance, including FDA/EMA guidelines (e.g., USP, Annex
  1) and management of inspections/deviations
• Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
• Lead Process Development & Transfer activities, including tech transfers, process optimization, Master Batch Records (MBRs) and SOPs
• Oversee Quality & Contamination Control activities such as environmental monitoring, media fills, gowning, cleaning, and root cause analysis for contamination events
• Develop training and provide technical leadership and expert support
• Execute process system engineering from conceptual/planning to final/detail design across projects from system enhancements to greenfield construction
• Collaborate with client personnel (Manufacturing, Facilities and Maintenance, Quality, Validation) to ensure designs meet current Good Manufacturing Practices
• Develop and interpret process construction documents (P&IDs, equipment GA drawings, piping plans, orthographic/isometric drawings, access platforms, BOMs, scopes of work, etc.)
• Interface with OEMs/vendors for equipment sizing and selection
• Develop project scopes and assist with proposals for engineering/design services and complete constructed solutions
• Stay abreast of new technologies and current Good Manufacturing Practices
• Make an impact day-to-day by strengthening client and team relationships

• 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 is a plus
• Willing and able to travel as necessary for project requirements, including installation and start-up activities, client meetings, trainings, industry seminars, forums, or conventions
• BS degree in Chemical, Mechanical or Bio Engineering is preferred; other degrees considered based on project experience

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