Process SME - Asceptic Processing - GMP Design

Genesis AEC • Whitpain Township, PA

11d • Hybrid

About The Position

The selected candidate will serve as the Aseptic Processing and GMP Design Subject Matter Expert (SME), advising AE teams and clients across project stages while maintaining current knowledge of regulatory environments, industry trends, and emerging equipment technologies. In this role, you will support aseptic processing and broader GMP projects across all stages of design, from front-end capital planning and feasibility through concept and detailed design, while contributing to key process engineering deliverables such as facility interface requirements, flow diagrams, equipment selections, technical reports, and quality reviews.

Requirements

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 15+ years of relevant experience in process engineering, aseptic processing, GMP facility design, or biopharmaceutical manufacturing environments.
• Demonstrated expertise in aseptic processing design, GMP facility planning, process equipment selection, and facility/process interface requirements.
• Strong understanding of applicable regulatory expectations and industry guidance related to sterile manufacturing, including FDA, EU GMP, and relevant industry standards.
• Experience supporting life sciences projects across multiple design phases, including feasibility, concept design, basis of design, detailed design, and quality review.
• Ability to serve as a technical subject matter expert for internal teams and clients, including advising on design strategy, risk assessment, regulatory considerations, and technical problem-solving.
• Strong communication, facilitation, presentation, and client-facing skills.
• Ability to mentor engineers, contribute to internal standards and tools, and support technical knowledge sharing across project teams.
• Ability to manage multiple priorities, work independently, and support project commitments in a hybrid work environment.

Nice To Haves

• Master’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Professional Engineer license (P.E.) or other relevant professional certification.
• Experience with both design-side and owner-side project environments.
• Prior experience contributing to proposals, client presentations, technical publications, conference presentations, or industry thought leadership.
• Active involvement in industry organizations such as ISPE, PDA, ASME BPE, or similar life sciences/biopharma groups.
• Experience developing or maintaining process engineering standards, design tools, specifications, details, or best practices.
• Experience mentoring or technically guiding process engineers, process architects, or multidisciplinary project teams.
• Familiarity with emerging aseptic processing technologies, sterile manufacturing equipment, contamination control strategies, and current industry trends.
• Strong proficiency with Microsoft Office applications and relevant engineering/design tools.

Responsibilities

• Serve as a key technical project resource, supporting deliverable development, quality reviews, process engineering standards, mentoring, proposal support, and thought leadership activities.
• Support aseptic processing and broader GMP projects across all stages of design, from front-end capital planning and feasibility through concept and detailed design.
• Contribute to key process engineering deliverables such as facility interface requirements, flow diagrams, equipment selections, technical reports, and quality reviews.
• Lead and guide process engineering teams through complex project work, helping develop deliverables, support quality reviews, troubleshoot technical challenges, and shape design strategies during front-end studies and early project development.
• Support regulatory reviews, risk assessments, facility definition efforts, peer reviews, and project guidance for process engineers and process architects across assignments.
• Strengthen the Process Engineering group by mentoring staff, facilitating internal training, and contributing to the development and maintenance of design standards, tools, details, specifications, and best practices.
• Represent Genesis as a trusted subject matter expert, building strong client relationships through excellent engineering, responsive service, and confident technical leadership.
• Support proposal development, participate in client presentations and project meetings, and help guide clients toward innovative, practical solutions.
• Contribute to early project and proposal discussions as an SME and represent Genesis Process Engineering at relevant conferences, symposiums, and industry events.
• Advance Genesis’ market leadership by creating technical content for publications and presentations, participating in industry forums, and strengthening the firm’s visibility in the life sciences community.
• Identify opportunities to engage in local and national industry events, including organizations such as ISPE, ASME BPE, and PDA, while helping recognize potential talent and strategic personnel who can support future growth.

Benefits

• Comprehensive medical, dental, vision, and RX insurance plans, with two-thirds of your premiums and deductible paid!
• Competitive 401(k) match program
• Generous paid time off (PTO)
• Paid Parental Leave time
• Thought leadership opportunities, including a $1,000 award for presenting or publishing your technical expertise!
• Competitive company-paid training opportunities
• A 5% salary increase for earning your professional license!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior