Process Equipment Engineer

Role Description: <ul><li>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.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile 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. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>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.</li></ul> Responsibilities: <ul><li>Lead 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.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

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Process Equipment Engineer

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Process Equipment Engineer

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