BW Design Group · 1 day ago
Principal, Process Engineer - Biologics
Concord, NH
Full-time
Onsite
Lead/Staff
$250K/yr - $275K/yr
20+ years expBW Design Group is a rapidly growing firm with a commitment to shaping the world through innovative engineering solutions. As a Principal Process Engineer in the Life Science Commercial Team, you will lead front-end design programming for Biologics processes, engage with clients, and contribute to technical business development efforts.
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
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
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
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
BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other degrees based on actual project experience
Benefits
Professional development resources
Mentorships
First Year Experience program
Individual Development Plans
Career Path resources and tools
Company
BW Design Group
BW Design Group is the only independent, fully integrated AEC firm powered by a Manufacturer's Mindset™.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Aderito Dos Santos
Partner
Adolfo Santana
Partner Quality and Regulatory Compliance Consulting Services
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