WhiteCrow Research
Process Equipment Engineer
WhiteCrow Research, Branchburg Township, New Jersey, United States
Overview
Join to apply for the
Process Equipment Engineer
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WhiteCrow Research We are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house research. About our client Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery. By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide. About the role The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility. This role will play a critical part in ensuring that all manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags. Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle. As a Process Equipment Engineer, you will be responsible for... Leading the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems. Developing user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards. Managing equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning. Promoting and ensuring adherence to safety protocols and safe work practices. Performing risk assessments for engineering and maintenance activities. Collaborating with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing. Establishing preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability. Providing technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues. Partnering with Manufacturing and Quality teams to optimize equipment performance, driving continuous improvement initiatives, and supporting ongoing process optimization. Identifying and implementing process improvements to enhance operational safety, efficiency, and reliability. Supporting development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment. Ensuring equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards. Contributing to capital project planning, budgeting, and project execution related to new equipment or facility expansions. Ensuring ongoing regulatory inspection readiness and serving as SME for process systems during audits and inspections. What you already have... Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field. 3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred. Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments. Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations. Experience working in greenfield or major facility expansion projects highly desirable. Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems. Proven project management skills with ability to handle complex, cross-functional projects. Excellent problem-solving abilities and root cause investigation experience. Effective communication and vendor management skills. Ability to work independently in a fast-paced, startup-like environment. Strong teamwork, collaboration, and continuous improvement mindset. High attention to detail with strong commitment to safety, compliance, and product quality. Seniority level
Associate Employment type
Full-time Industry
Pharmaceutical Manufacturing
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Join to apply for the
Process Equipment Engineer
role at
WhiteCrow Research We are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house research. About our client Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery. By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide. About the role The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility. This role will play a critical part in ensuring that all manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags. Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle. As a Process Equipment Engineer, you will be responsible for... Leading the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems. Developing user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards. Managing equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning. Promoting and ensuring adherence to safety protocols and safe work practices. Performing risk assessments for engineering and maintenance activities. Collaborating with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing. Establishing preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability. Providing technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues. Partnering with Manufacturing and Quality teams to optimize equipment performance, driving continuous improvement initiatives, and supporting ongoing process optimization. Identifying and implementing process improvements to enhance operational safety, efficiency, and reliability. Supporting development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment. Ensuring equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards. Contributing to capital project planning, budgeting, and project execution related to new equipment or facility expansions. Ensuring ongoing regulatory inspection readiness and serving as SME for process systems during audits and inspections. What you already have... Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field. 3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred. Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments. Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations. Experience working in greenfield or major facility expansion projects highly desirable. Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems. Proven project management skills with ability to handle complex, cross-functional projects. Excellent problem-solving abilities and root cause investigation experience. Effective communication and vendor management skills. Ability to work independently in a fast-paced, startup-like environment. Strong teamwork, collaboration, and continuous improvement mindset. High attention to detail with strong commitment to safety, compliance, and product quality. Seniority level
Associate Employment type
Full-time Industry
Pharmaceutical Manufacturing
#J-18808-Ljbffr