Barry-Wehmiller · 1 month ago
Principal Process Engineer – API + OSD
St. Louis, MO
Full-time
Onsite
Lead/Staff
$250K/yr - $275K/yr
20+ years expBarry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology. As a Principal Process Engineer, you will lead front end design programming for API and OSD processes, engage with clients, and contribute to business development efforts while ensuring compliance with regulatory standards.
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 Active Pharmaceutical Ingredients (APIs) and/or Oral Solid Dose (OSD) 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 API and/or OSD 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
Deep understanding of FDA/EMA guidelines (like USP <1116>, Annex 1) and managing inspections/deviations
Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial-scale manufacturing
Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
Establish process parameters, control strategies, and manufacturing specifications for API production
Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial-scale manufacturing
Conduct feasibility assessments, process characterization studies, and technology evaluations to support process selection
Establish process parameters, control strategies, and manufacturing specifications for API production
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). Familiarity with 3D modeling, computer-based hydraulic analysis and process simulation software skills are considered a plus
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
Company
Barry-Wehmiller
We’re Building A Better World. We’re more than just a successful capital equipment and engineering solutions firm.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Bob Chapman
CEO and Chairman
Doug McGraw
President & CEO, BW Flexible Systems
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