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BW Design Group · 2 weeks ago

Principal Process Engineer - Aseptic Fill & Finish

Raleigh, NC

Full-time

Onsite

Lead/Staff

$250K/yr - $275K/yr

20+ years exp

BW Design Group is a rapidly growing company that is seeking a Principal Process Engineer to join their Life Science Commercial Team. In this role, you will lead front-end design programming for aseptic processes and be responsible for developing innovative solutions while ensuring compliance with regulatory standards.

Industrial Automation

Hiring Manager

Jimmy Fortese

Responsibilities

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 Aseptic 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 Aseptic facility & 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 Aseptic 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

Deep understanding of FDA/EMA guidelines (like USP , Annex 1) and managing inspections/deviations

Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products

Mastery of isolators, RABS, VHP decontamination, peristaltic/piston pumps, visual inspection

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

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

Qualification

Aseptic ProcessingCGMP & Regulatory ComplianceProcess Development & TransferQuality & Contamination ControlTechnology & EquipmentProposal GenerationTechnical TrainingClient EngagementAutoCADMicrosoft OfficeMicrosoft ProjectCommunicationTeam LeadershipProject Management

Required

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

Preferred

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

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