Principal, Process Engineer - Biologics

Barry-Wehmiller•Indianapolis, IN

About The Position

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. When you join Design Group as a Principal Process Engineer, you are joining a team that will challenge you and position you for growth. In this role, 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 the highest 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 (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 Biologics 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 Biologics 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. Prior responsible charge expertise developing Biologics process operations by defining concepts, generating client engagement/alignment, evaluating existing processes/operations, defining scale/modality appropriate solutions, aligning integration approach, and providing the qualification strategy for both traditional processing methods and emerging technologies to align industry standards with regulatory guidance. 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. 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

Requirements

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

Nice To Haves

Familiarity with 3D modeling, computer-based hydraulic analysis and process simulation software skills are considered a plus.

Responsibilities

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.
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 Biologics 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.
Prior responsible charge expertise developing Biologics process operations by defining concepts, generating client engagement/alignment, evaluating existing processes/operations, defining scale/modality appropriate solutions, aligning integration approach, and providing the qualification strategy for both traditional processing methods and emerging technologies to align industry standards with regulatory guidance.
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
Deep understanding of FDA/EMA guidelines (like USP <1116>, Annex 1) and managing inspections/deviations.
Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
Leading tech transfers, optimizing processes, and developing Master Batch Records (MBRs) and SOPs.
Overseeing environmental monitoring, media fills, gowning, cleaning, and root cause analysis for contamination events.
Developing and delivering technical training, acting as a technical lead, and providing expert support.