Sr. Process Engineer

BW Design Group; Raleigh (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

BW Design Group in Raleigh, NC is seeking a Sr. Process Engineer with 5+ years in pharmaceutical/biologics process systems. You will work with our clients on capital projects, guiding design teams and delivering compliant, scalable solutions.

You’ll design PFDs and P&IDs, develop mass balances, and collaborate with manufacturing, QA and validation to meet GMP. Occasional travel to client sites is expected, with opportunities for mentorship and career growth.

Qualifications

• Minimum 5 years of pharmaceutical and biologics process system engineering/design experience.
• Experience with CIP/SIP, WFI/RODI systems.
• Familiar with FDA/EMA regulatory standards.
• Proficient with CAD, MS Office, and project management tools.

Responsibilities

• Process mechanical design within multi-discipline teams in an A&E environment.
• Lead process system engineering from conceptual to detail design for diverse projects.
• Coordinate with manufacturing, facilities, QA and validation to ensure GMP-compliant designs.
• Develop PFDs, P&IDs, energy/mass balances and equipment specs.
• Provide onsite support during commissioning and startup.

Skills

Excellent communication

Team leadership

Pharma/biologics process systems

CAD basics

Education

BS in Chemical/Mechanical/Bio Engineering

Tools

AutoCAD

Microsoft Project

3D modeling

Process simulation software

Job description

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.
When you join Design Group as a Sr. Process Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Architecture/Engineering Process Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

You‘ve work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.
High energy and collaborative Process Engineer or Senior Process Engineer who will work with and guide our process engineering team on a broad range of client life sciences projects. This role may require leadership at client sites.

• Process mechanical design as part of multi-discipline project teams in an A&E environment.
• 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.
• Process mechanical design of processes and equipment used in the manufacture of sterile product within the pharmaceutical, biological, and medical device industries.
• Develop process flow diagrams (PFDs)preparing energy and mass balances, conducting cycle time and bottleneck analysis, equipment selection, sizing and specifications, utility requirements matrix, and gap analysis, etc.
• 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.
• Directs the work performed by CAD designers.
• Facilitates design coordination with controls/automation, utilities, and building systems.
• Provides onsite support as needed during system testing, start-up, commissioning, and qualification.
• 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

What You’ll Bring

• Minimum of 5 years of pharmaceutical and biologics process system engineering/design experience.
• Knowledge and design experience including CIP/SIP, Support Equipment (Washers, Autoclaves, Lyophilizers), and High Purity Water Systems (WFI and RODI).
• Working knowledge of process definition means and methods including identifying process unit operations required
• Experience with FDA and EMA regulatory standards.
• Familiar with process control methodologies, types of control valves and instrumentation, developing functional specifications, and comfortable working with automation engineers.
• 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.
• BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Sr. Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.