IDOM USA
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This range is provided by IDOM USA. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $140,000.00/yr
Direct message the job poster from IDOM USA
Making Connections, Helping Others Find Careers This position is related to pharmaceutical industry to work in US and international projects. Experience in this field is absolutely required.
Primary Responsibilities The Lead Process Engineer is responsible for leading the process design and integration of pharmaceutical manufacturing systems, ensuring alignment with cGMP, regulatory, and client requirements. This role oversees the development of process design deliverables, coordination with multidisciplinary teams, and technical leadership throughout all project phases—from conceptual design to validation and commissioning. The position will require an ability to make independent decisions on engineering problems and methods, articulating solutions to the team, and while not a supervisory position may need to direct the work of other engineers and designers on projects.
Lead the process engineering design for new and retrofit pharmaceutical facilities, including API, oral solid dosage (OSD), biotech, and aseptic processing plants.
Develop and approve PFDs, P&IDs, mass and energy balances, and process flow schematics.
Select and size process equipment
Define process utilities (WFI, clean steam, process air/gas, and CIP return systems).
Ensure material compatibility, hygienic design, and proper segregation for containment or sterile operations.
Act as discipline lead coordinating process scope with HVAC, electrical, controls, structural, and architectural teams.
Interface with clients, validation, and operations teams to align process requirements with facility layout and utility capacities.
Oversee preparation of engineering documents, data sheets, and equipment specifications.
Manage and guide junior process engineers, reviewing their calculations, drawings, and documentation.
Ensure that design deliverables comply with schedule, budget, and quality standards.
Ensure full compliance and integrate process validation (DQ/IQ/OQ/PQ) and quality risk management principles into design deliverables.
Prepare and review documentation for process qualification and regulatory submissions.
Prepare equipment specifications, inquiry packages, and bid evaluations for process systems and skids.
Minimum Qualifications
Bachelor’s or Master’s degree in Chemical Engineering or Process Engineering.
6+ years of experience in process design for pharmaceutical or biotech manufacturing facilities.
Proven knowledge of cGMP regulations, FDA/EMA guidelines, and ISPE Baseline standards.
Strong experience with process simulation and design software (Aspen Plus, AutoCAD Plant 3D, Revit, or equivalent).
Excellent communication and client interface skills.
Ability to provide excellent customer service, work well in a collaborative environment, and demonstrate effective team‑building skills.
Flexible and dynamic team player capable of integrating into an international team.
Preferred Qualifications
PE or chartered engineer license.
Aseptic and sterile process design.
Hygienic piping and equipment design (ASME BPE).
Process safety and containment (toxic APIs, biosafety).
Process utility integration (clean steam, WFI, PW, HVAC interfaces).
$110k - $140k per year, depending on all candidate factors; such as qualifications, experience level, etc.
Work‑Life Balance, Flexible Hours, and remote working days.
Long term career path, including partner opportunity, in a multicultural and multidisciplinary environments.
Idom is an employee‑owned international engineering, architectural and consulting firm. Our company has more than 5500 professionals in 45 offices in the Americas, Europe, North Africa, and the Middle East. In the US we emphasize providing professional engineering and consulting services to the sectors of Power, Petrochemical, Renewable Energy, Astronomy, Research Test Facilities, Manufacturing, Pulp and Paper, Pharmaceutical and the Food and Beverage market sectors. Our company has been in business since 1957. We have a backlog of interesting and technically challenging projects in the US and worldwide. Please refer to our global website, www.IDOM.com.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Project Management, Engineering, and Design
Industries Pharmaceutical Manufacturing and Chemical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
This range is provided by IDOM USA. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $110,000.00/yr - $140,000.00/yr
Direct message the job poster from IDOM USA
Making Connections, Helping Others Find Careers This position is related to pharmaceutical industry to work in US and international projects. Experience in this field is absolutely required.
Primary Responsibilities The Lead Process Engineer is responsible for leading the process design and integration of pharmaceutical manufacturing systems, ensuring alignment with cGMP, regulatory, and client requirements. This role oversees the development of process design deliverables, coordination with multidisciplinary teams, and technical leadership throughout all project phases—from conceptual design to validation and commissioning. The position will require an ability to make independent decisions on engineering problems and methods, articulating solutions to the team, and while not a supervisory position may need to direct the work of other engineers and designers on projects.
Lead the process engineering design for new and retrofit pharmaceutical facilities, including API, oral solid dosage (OSD), biotech, and aseptic processing plants.
Develop and approve PFDs, P&IDs, mass and energy balances, and process flow schematics.
Select and size process equipment
Define process utilities (WFI, clean steam, process air/gas, and CIP return systems).
Ensure material compatibility, hygienic design, and proper segregation for containment or sterile operations.
Act as discipline lead coordinating process scope with HVAC, electrical, controls, structural, and architectural teams.
Interface with clients, validation, and operations teams to align process requirements with facility layout and utility capacities.
Oversee preparation of engineering documents, data sheets, and equipment specifications.
Manage and guide junior process engineers, reviewing their calculations, drawings, and documentation.
Ensure that design deliverables comply with schedule, budget, and quality standards.
Ensure full compliance and integrate process validation (DQ/IQ/OQ/PQ) and quality risk management principles into design deliverables.
Prepare and review documentation for process qualification and regulatory submissions.
Prepare equipment specifications, inquiry packages, and bid evaluations for process systems and skids.
Minimum Qualifications
Bachelor’s or Master’s degree in Chemical Engineering or Process Engineering.
6+ years of experience in process design for pharmaceutical or biotech manufacturing facilities.
Proven knowledge of cGMP regulations, FDA/EMA guidelines, and ISPE Baseline standards.
Strong experience with process simulation and design software (Aspen Plus, AutoCAD Plant 3D, Revit, or equivalent).
Excellent communication and client interface skills.
Ability to provide excellent customer service, work well in a collaborative environment, and demonstrate effective team‑building skills.
Flexible and dynamic team player capable of integrating into an international team.
Preferred Qualifications
PE or chartered engineer license.
Aseptic and sterile process design.
Hygienic piping and equipment design (ASME BPE).
Process safety and containment (toxic APIs, biosafety).
Process utility integration (clean steam, WFI, PW, HVAC interfaces).
$110k - $140k per year, depending on all candidate factors; such as qualifications, experience level, etc.
Work‑Life Balance, Flexible Hours, and remote working days.
Long term career path, including partner opportunity, in a multicultural and multidisciplinary environments.
Idom is an employee‑owned international engineering, architectural and consulting firm. Our company has more than 5500 professionals in 45 offices in the Americas, Europe, North Africa, and the Middle East. In the US we emphasize providing professional engineering and consulting services to the sectors of Power, Petrochemical, Renewable Energy, Astronomy, Research Test Facilities, Manufacturing, Pulp and Paper, Pharmaceutical and the Food and Beverage market sectors. Our company has been in business since 1957. We have a backlog of interesting and technically challenging projects in the US and worldwide. Please refer to our global website, www.IDOM.com.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Project Management, Engineering, and Design
Industries Pharmaceutical Manufacturing and Chemical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr