Lead Process Engineer, Design

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead Process Engineer, Design based in the United States.** We are seeking an experienced Lead Process Engineer to design and optimize manufacturing processes for technically complex facilities, particularly within the pharmaceutical and biotechnology industries. In this role, you will support projects ranging from developmental pilot plants to full-scale commercial production, translating process requirements into practical, efficient, and reliable engineering solutions. You will lead key process design activities, develop technical documentation, and help ensure that manufacturing systems meet operational and regulatory requirements. Working closely with multidisciplinary design teams and clients, you will contribute to facility expansions, process improvements, and automation initiatives. You will also support the development of innovative engineering tools and take ownership of process engineering deliverables across projects of varying sizes. This opportunity offers remote work flexibility, collaboration with technical experts, and the chance to contribute to critical life sciences manufacturing projects. ### 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.