Lead Process Engineer, Design.

Accountabilities:

• Develop process design deliverables: Prepare conceptual engineering documents, including Process Flow Diagrams (PFDs), material balances, and energy balances for manufacturing processes.

• Design utility systems: Estimate utility requirements for new manufacturing processes and design utility generation and distribution systems to support facility operations.

• Prepare process and utility P&IDs: Develop Process and Instrumentation Diagrams (P&IDs), preferably using AutoCAD, incorporating control strategies and Clean-in-Place (CIP) and Steam-in-Place (SIP) functions where appropriate. Prepare P&IDs for critical utilities, including Water for Injection (WFI), USP Purified Water, and Clean Steam.

• Improve existing facilities: Conduct engineering studies to expand, improve, or automate existing manufacturing facilities, working independently with limited supervision.

• Specify equipment and instrumentation: Develop equipment specifications and performance data sheets to support process design and implementation.

• Support engineering tools and innovation: Use and contribute to the development of internal design and production tools, including process simulation software and intelligent P&ID systems.

• Lead process engineering activities: Take ownership of process-related workstreams within large projects or manage the process engineering scope of smaller projects, providing technical guidance to the wider design team.

• Collaborate with clients and colleagues: Build and maintain effective working relationships with clients and multidisciplinary engineering teams to ensure project alignment and successful delivery.

• Contribute to special projects: Support additional engineering assignments and project activities as required.

Requirements:

• Education: Bachelor’s degree in Chemical Engineering.

• Professional experience: At least 10 years of engineering experience, including a minimum of five years in process design. Experience in the pharmaceutical or biotechnology industries is preferred.

• Regulatory and technical knowledge: Understanding of current Good Manufacturing Practices (cGMP) and their implications for process design and equipment specifications.

• Process engineering expertise: Ability to develop process flow diagrams, material and energy balances, P&IDs, utility system designs, and equipment specifications.

• Analytical and problem-solving skills: Ability to evaluate manufacturing processes, conduct engineering studies, identify improvement opportunities, and develop practical technical solutions.

• Project ownership: Ability to manage process engineering deliverables independently, coordinate technical activities, and support projects from conceptual design through implementation.

• Communication and collaboration: Strong interpersonal skills and the ability to establish effective working relationships with clients and multidisciplinary project teams.

• Travel and transportation: Willingness and ability to travel approximately 5–20%, or as required by assigned projects. Extended client-site assignments and overnight stays may be necessary. Reliable transportation and the ability to commute routinely are required.

• Physical capabilities: Ability to stand, sit, and walk for extended periods; stoop, kneel, crouch, and crawl when required; lift and move objects weighing up to 25 pounds; and climb ladders as needed.

• Work environment and safety: Ability to work in indoor and outdoor environments with varying conditions, comply with strict cleanroom gowning protocols, and follow client-site safety requirements. This is a safety-sensitive role that includes work in non-administrative areas such as construction, manufacturing, packaging, research, and process operations.

• Interview requirements: Availability to participate in interviews either in person or virtually, with video required for virtual interviews.

Benefits:

• Competitive salary: Annual salary range of $113,000–$150,000, depending on experience, skills, and education.

• Remote work flexibility: Full-time remote work is available for this position.

• Professional development: Opportunities to expand technical expertise through complex process engineering and life sciences manufacturing projects.

• Collaborative environment: Work alongside multidisciplinary engineering professionals and engage directly with clients on technically challenging assignments.

• Additional benefits: Specific details regarding healthcare coverage, retirement plans, paid time off, and other employee benefits are not provided in the supplied job description.