Process Engineer

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 include:

• 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 include:

• 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…