Senior Process Engineer

Genesis AEC • Whitpain Township, PA

18d • Hybrid

About The Position

We are seeking a Senior Process Engineer to join our exceptional team. This role offers significant growth potential and the opportunity to lead the process discipline on high-visibility projects. The position provides opportunities for personal development and growth, as well as supporting and mentoring junior process engineers. Responsibilities include leading process projects across a broad range of potential process types, with a high-level focus on areas such as biotechnology, oral solid dosage, and aseptic processing. Based on experience, a preferred area of expertise can be targeted or a range of assignments can be provided to support overall growth and flexibility. Our collaborative culture ensures that our clients benefit from top-tier work across our entire range of professional offerings.

Requirements

• BS in Chemical Engineering or Mechanical Engineering
• 10+ years of experience associated with the design and development of cGMP operations and equipment in the Life Sciences industry.
• Experience with the design and/or operation of cGMP manufacturing systems.
• Ability to effectively communicate process concepts to clients and peers
• Intermediate to advanced level skills with Microsoft Office software
• Strong written and oral communication skills
• Ability to work well under pressure and to prioritize multiple projects while adjusting work against deadlines

Nice To Haves

• Experience with cGMP design in both the A&E business and operating company in the Life Sciences industry.
• General experience across a range of processes (biotech, API, OSD, aseptic processing, etc.) or proven and demonstrated expertise in one or more areas of pharmaceutical manufacturing.
• Experience with Supervisory Control and Data Acquisition (SCADA) systems, including a basic understanding of how to apply such systems on a process-driven project.
• Published author regarding cGMP design or a desire to do so in the future.
• ISPE and/or PDA involvement/leadership.
• P.E. Registration or a path toward licensure.

Responsibilities

• Develop and maintain typical process engineering deliverables, including but not limited to: Block/Process Flow Diagrams, Mass Balances, Process Equipment Lists, Utility Summaries, P&IDs, Equipment Specification packages, Process Simulation modeling, Hydraulic calculations, line sizing, equipment sizing, etc.
• Execute and/or direct the development of calculations or process simulations as necessary to support the process design effort.
• Lead or participate in Process Hazard Analyses (PHAs) and regulatory or quality Risk Assessments.
• Assist in the development of documents for inclusion in construction packages (e.g., system descriptions, BODs, URS’s, flow diagrams, material and energy balances, P&IDs, datasheets, and equipment specifications).
• Collaborate with Process Automation to support the development of and review the creation of process automation concepts and determine instrumentation requirements.
• Ensure that other project disciplines (e.g., architectural, process utilities, mechanical, electrical, plumbing) understand the applicable process requirements and interfaces.
• Ensure designs are compliant with regulatory (e.g., FDA, EU Annex 1) and industry (e.g., ISPE, BPE) requirements and guidance.
• Ensure designs are compliant with environmental and safety practices.
• Lead process-driven projects independently or manage a small team of process engineers on more complex projects.
• Support a range of projects at any project phase, from feasibility through detailed design and construction support.
• Define process requirements, lead client engagement, and develop process understanding deliverables.
• Guide junior and mid-level process engineers in the development of deliverables.
• Delegate assignments to process staff and guide their work.
• Assess and analyze data, integrate, and lead the development of concepts to create designs and/or reports.
• Develop and provide solutions for clients that optimize operations, facility flows, and utility consumption.
• Direct the collection of appropriate data from clients to develop/define process requirements and clearly document design basis for collaboration/development.
• Present results and recommendations to clients; assist in gathering input and feedback to strengthen designs.
• Facilitate and document workshops, including Risk Assessments and Process Hazard Analyses.
• Lead client interface and provide project management when required.
• Prepare scope and hourly estimates for various process work in preparation for client proposals.
• Ability to assist with Business Development by nurturing client relationships and identifying potential project opportunities.
• Prepare process design plan per project, including resource requirements and execution plan to complete design.
• Perform quality checks of work completed by others on the process team.
• Stay current with EU and FDA regulations and trends regarding ever-changing regulatory requirements of pharmaceutical manufacturing.
• Collect information from industry sources to help clarify design and industry best practices.
• Recruit lead engineers and process engineers to continue to enhance and expand the Process Department at Genesis.

Benefits

• Comprehensive medical, dental, vision, and RX insurance plans, with two-thirds of your premiums and deductible paid!
• Competitive 401k match program
• Generous paid time off
• 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