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Full-time
bachelor degree, postgraduate degree
Posted 13d ago
~40 hrs/week
Responsibilities
The Lead Process Engineer will serve as the technical authority for process design and execution on API small molecule facility projects. Responsibilities include leading engineering deliverables, ensuring regulatory compliance, and providing field support during construction and commissioning.
Requirements
Candidates must hold a Bachelor’s or Master’s degree in Chemical Engineering and possess over 10 years of experience in process engineering with a focus on EPC projects. A Professional Engineer (PE) license and proficiency in process simulation tools like Aspen Plus or HYSYS are required.
Full job description
Discover your exciting role
The Lead Process Engineer will serve as the technical authority for process design and execution on EPC projects involving Active Pharmaceutical Ingredient (API) facilities, with a focus on small molecule drug substances. This role will lead process engineering activities across all project phases—conceptual design, FEED, detailed engineering, and construction insuring compliance with client specifications, regulatory standards, and project objectives.
Explore your tasks and responsibilities
Process Design Leadership: Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), material and energy balances, and equipment specifications for API small molecule facilities.
Project Execution: Lead process engineering deliverables for EPC projects, including design basis documents, process narratives, and datasheets.
Regulatory & cGMP Compliance: Ensure designs meet pharmaceutical regulatory requirements, including cGMP, FDA, EMA, and ICH guidelines.
Client Interface: Act as the primary process engineering contact for clients, providing technical guidance and ensuring alignment with project goals.
Risk & Safety Analysis: Conduct HAZOP, risk assessments, and ensure compliance with EHS standards.
Construction & Commissioning Support: Provide field engineering support during installation, commissioning, and start-up phases.
Team Leadership: Mentor junior engineers and coordinate with multi-disciplinary teams (mechanical, electrical, automation) to deliver integrated solutions.
Other duties as assigned
Show your expertise
Minimum Requirements:
Education: Bachelor’s or Master’s degree in Chemical Engineering.
Experience: • 10+ years in process engineering, with at least 5 years in EPC project execution for pharmaceutical or chemical facilities. • Strong background in API small molecule processes and facility design. • Professional Engineer (PE) License • Nation Council of Examiners for Engineering and Surveying (NCEES) Record
Technical Skills: • Proficiency in process simulation tools (Aspen Plus, HYSYS) and engineering standards. • Knowledge of cGMP, regulatory compliance, and cleanroom design principles.
Soft Skills: • Strong leadership, communication, and client-facing skills. • Ability to manage multiple priorities in a fast-paced EPC environment.
Preferred • Professional Engineer (PE) License preferred • Nation Council of Examiners for Engineering and Surveying (NCEES) Record preferred • Experience with modular construction and advanced manufacturing technologies • Familiarity with ISPE guidelines and QbD principles • Prior involvement in large-scale greenfield or brownfield pharmaceutical projects • Prior experience in consulting engineering
Contact:
You want to be part of the Exyte team? We look forward to receiving your application! For further questions and information, please do not hesitate to contact Tina Denny.
Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.
Exyte US, Inc. is proud to be an Equal Employment Opportunity employer that is committed to celebrating diversity and supporting an inclusive workplace where associates excel based on personal merit, qualifications, experience, ability, and job performance. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex (e.g., pregnancy, childbirth and related medical conditions, sexual orientation, gender identity), national origin, disability, genetic information, protected veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
Related keywords
Process EngineeringAPISmall MoleculeEPCFEEDPFDP&IDcGMPFDAEMAICHHAZOPEHSAspen PlusHYSYSCleanroom Design
The manufacturing processes of our clients are subject to high standards and require our expertise in controlled and regulated environments. We provide the manufacturing facilities with ultra-clean air and ultra-pure atmospheres, ensure air temperature and humidity control, and meet the client's specific requirements – for example, specifications regarding differential pressure or noise insulation.
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