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Barry-Wehmiller · 1 month ago

Principal Process Engineer - Aseptic Fill & Finish

Raleigh, NC USA

Full-time

Onsite

Lead/Staff

$250K/yr - $275K/yr

20+ years exp

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology. The Principal Process Engineer will work with a team of industry experts to help leading companies solve complex problems in aseptic processing and will be responsible for client engagement, technical development, and innovative solution delivery.

Machinery

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

Prior responsible charge expertise developing Aseptic facility & process operations

Passionate industry expert with outgoing personality

Deep understanding of FDA/EMA guidelines

Expertise in sterilization, aseptic filling, 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 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

Works closely with Client personnel including Manufacturing, Facilities and Maintenance, Quality, and Validation

Understanding and development of process construction documents

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

Stays abreast of new and emerging technologies

Qualification

CGMP & Regulatory ComplianceAseptic ProcessingProcess Development & TransferQuality & Contamination ControlTechnology & EquipmentTraining & LeadershipProposal GenerationComputer SkillsFront-end/Feasibility Study ExperienceCommunication Skills

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