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.
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Some local travel to Client Sites is expected, as needed. Limited national travel could be 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.
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
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.
Our collaborative and positive culture sets us apart
We offer hybrid work schedules and half-day Fridays year-round.
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!