Senior Process Engineer

SENIOR PROCESS ENGINEER

Do you have an innate curiosity when it comes to learning, implementing, and integrating the different pieces of a design puzzle? Are you seeking the next step in your career that offers significant growth potential?

If so, we invite you to apply for our exceptional team as a Senior Process Engineer!

WHO WE ARE:

We're Genesis AEC - an award-winning architecture, engineering, construction management, and CQV firm and a leader in the life sciences industry. Ranked #5 in Pharmaceutical Design by ENR magazine, we're designing and constructing facilities that advance worldwide health. We're proud to contribute to our Clients' success, earning honors that include a 2021 ISPE Facility of the Year (FOYA) award and an ENR Mid-Atlantic's Best Manufacturing Project award for our work at the National Institutes of Health.

Our culture is based on inclusion, one where all identities, backgrounds, and perspectives are embraced. When you're on our team, you'll find you are supported, challenged, and encouraged to grow - with opportunities, training, and a work-life balance to help you succeed.

This is a tremendous opportunity for a dedicated individual who wants to lead the process discipline on high-visibility projects. This position provides opportunities for personal development and growth as well as supporting and mentoring junior process engineers. The responsibilities of this position 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 - each with its own diverse subsets of process types. 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.

WHAT YOU WILL BE DOING

The Senior Process Engineer will be client-facing and support front-end project definition through facilitated client engagement. The process engineer begins by understanding and assessing client process requirements, including infrastructure impacts, and supporting the design of cGMP-compliant facilities that meet these requirements. The engineer will develop project deliverables that represent scope understanding and drive overall project definition. The Senior Process Engineer will effectively collaborate with other disciplines, starting with architecture, to support the development of initial adjacency diagrams and facility layouts. This is followed by communications with process utilities, mechanical, electrical, and plumbing disciplines to support overall facility infrastructure design.

The ideal candidate will determine how to add value given each project's unique circumstances - knowing when to employ production simulation tools for right-sizing of the facility based on required throughput; providing sound recommendations for efficient and effective operations backed up by modeling and calculations; and providing solutions that address the project's given challenges.

A Senior Process engineer should be conversant with the design and specification of cGMP systems and equipment. Client interface skills, communication skills, delegation of tasks, and leadership skills are required for this position. This role also includes proposal preparation and sales presentations to potential clients.


Senior Process Engineer

Responsibilities / Role Expectations

• 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.

Operations

• 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.

Client Facing

• 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.
• Some local travel to Client Sites is expected, as needed. Limited national travel could be required.

Strategic

• 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.

YOU MAY BE A GOOD FIT IF YOU MEET THESE REQUIREMENTS

Minimum Qualifications:

• 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

Preferred Qualifications:

• 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.

WHY YOU'LL LOVE IT HERE:

• 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!
• Endless opportunities to grow your career
• And so much more!

Are you ready to unlock your potential with us? With your passion and our vision, there's no limit to what you can accomplish here! Submit your resume today for immediate consideration.