Process Engineer

This role will primarily support pharmaceutical, biotech, and life sciences clients, as well as select projects in other regulated manufacturing environments where process control, documentation, and compliance are critical to operations.

The Process Engineer will provide technical support to Engineering Design, Construction Management, and CQV/Start-up teams on facility and process projects within regulated manufacturing environments, including pharmaceutical and life sciences facilities operating under cGMP requirements.

This role supports engineering design, capital project execution, and ongoing system improvements within operating facilities and greenfield projects, through development of technical documentation and participation in commissioning, process optimization, and system lifecycle activities.
Candidates with experience in regulated environments are strongly preferred; candidates without direct pharmaceutical experience should demonstrate clearly transferable experience aligned with regulated manufacturing systems

Responsibilities:

• Project Support:

• Support and contribute to the design of clean utilities, process equipment, and manufacturing systems across project phases, including development of engineering deliverables and full system design.
• Participate in and execute capital projects within operating facilities, supporting system modifications, expansions, and upgrades from scope development through implementation. Work across projects involving clean utilities, process equipment, and manufacturing systems in both new installations and existing operations.

• Collaboration:

• Work independently while leveraging internal, client, and industry resources to deliver accurate and efficient solutions. Build and maintain strong professional relationships with team members, clients, and partners, and remain composed in fast-paced or high-pressure environments.

• Documentation:

• Maintain accurate and comprehensive project documentation, including design specifications, test plans, and progress reports. Collect, record, analyze, and document data and analytical results. Develop and manage documentation in accordance with both engineering design processes (internal project execution and deliverables) and controlled documentation systems within regulated environments, including cGMP requirements, validation activities, and change control processes.

• Communication:
• Communicate effectively with clients, contractors, and project teams regarding technical scope, deliverables, and compliance requirements, including the ability to engage with stakeholders at technical, managerial, and executive levels.
• Ensure timely and accurate transfer of information in environments requiring controlled documentation and coordination across multiple stakeholders.
• Proactively identify and communicate issues, risks, or knowledge gaps, leveraging internal resources and technical networks to ensure accurate and efficient project execution.
• Innovation:
• Develop and implement solutions to process and system challenges, collaborating with cross-functional teams to address client needs.
• Contribute to a collaborative environment by generating and evaluating new ideas, supporting implementation of improvements, and helping teams navigate and adopt changes within project and operational settings.

Qualifications and Experience:

• Education:

• Bachelor's degree in Engineering (Chemical, Mechanical, or equivalent preferred)
• Equivalent education and experience may be considered for candidates with significant experience supporting pharmaceutical, biotech, or other regulated manufacturing environments.

• Experience:
• 0-5 years of process engineering experience, preferably in:
• Pharmaceutical, biotech, or life sciences industries.
• OR other regulated manufacturing environments (e.g., food & beverage, semiconductor, or cleanroom-based industries).

• Candidates without direct pharmaceutical experience may be considered if they have relevant, transferable experience, such as:

• Clean utilities (WFI, clean steam, purified water)
• Industrial or process utilities (clean/black utilities, HVAC systems)
• Semiconductor or cleanroom environments
• Food & beverage or other regulated manufacturing systems
• Relevant manufacturing equipment or process system design

• Candidates with more than 3 years of experience are expected to demonstrate either direct pharmaceutical exposure or clearly transferable experience within regulated environments.
• EIT/FE certification or progress toward professional licensure is a plus.
• Professional Engineer (PE) license is considered an asset for candidates supporting complex design or capital projects, but is not required.

• Technical Skills:
• Demonstrated application of process engineering fundamentals to support design, implementation, and optimization of process, utility, and manufacturing systems across project phases.
• Experience developing and interpreting engineering deliverables, including PFDs, P&IDs, mass and energy balances, equipment specifications, and system design documentation.
• Working knowledge of process systems, utilities, and equipment, including clean utilities, process equipment, and supporting infrastructure within pharmaceutical manufacturing or other regulated environments.
• Familiarity with engineering principles including fluid flow, heat transfer, mass balance, and pressure safety, applied in the context of real-world system design and operation.
• Experience or exposure to regulated environments (cGMP or similar frameworks), including understanding of how engineering activities integrate with controlled documentation, validation, and change control processes.

• Adaptability: Flexibility and willingness to work on various projects and tasks, embracing new challenges with enthusiasm.

• Initiative: Demonstrated ability to work independently and take initiative to drive projects forward.

• Nice to Have:

• Experience supporting capital projects within operating facilities, including system upgrades, expansions, or process improvement.
• Experience with one or more of the following within pharmaceutical, life sciences, or other regulated environments:
  • Clean utilities, process equipment, or manufacturing systems
  • Maintenance programs, CMMS systems, or GMP-aligned maintenance practices supporting compliant system operation and lifecycle management
• Prior experience working in pharmaceutical, biotech, life sciences, or adjacent regulated industries such as food & beverage, semiconductor, or other cleanroom/manufacturing environments
• Experience supporting CQV activities, including commissioning, qualification, or validation execution.
• Experience working with regulated documentation systems, including deviation management, CAPA, and change control processes.

Location: This is not a remote role. This position will be required to report to a client site in Raleigh, NC, Houston, TX, or other client sites.

Travel: Flexibility and willingness for travel based on project needs.

Compensation & Benefits:

Actual compensation will be determined based on a number of factors including skills, experience, qualifications, and location. This role is also eligible for performance-based bonuses, and a comprehensive U.S. based benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off and company holidays
• Wellness programs and employee assistance resources
• Professional development support

For more information, visit our full benefits overview here.