Process Equipment Engineer

Chemical Engineer – Relief Systems Process Safety

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>

Responsibilities:Evaluate, design and document vessels for potential over pressure and vacuum scenarios (new & existing) – relief device (PSV, RD, conservation vents) relief load calculation, inlet and outlet line sizing, size selection and datasheet preparation, and relief/flare load summary preparation. Design, model, document, and communicate requirements for pressure/vacuum relief devices and effluent handling.Understanding of mechanical design conditions and to utilize the process safety information in designing relief system to safeguard piping and equipment.Understanding of HAZOP, PHA report, SIL studies - provide relief system input from these reports. Design of overpressure protection for gas/vapor filled systems using Depressurization concept. Material & Energy Balance Calculation as per the process requirement to design the adequate relief systems.Work to enhance safety and protection of the environment through overall relief project development.Stay abreast of corporate and industry relief practices and standards such as API 520/521, NFPA 30, API 2000 etcRequirements:3 to 8 years of direct Relief Systems experience in process design, commissioning, start-up, or operations.Demonstrated project management skills. Proficiency with Microsoft Office programsPrefer knowledge in application and compliance requirements of regulatory codes: US Occupational Health and Safety Administration, Internal Process Safety StandardsExperience in a petrochemical plant or refinery Experience with the following software would be an advantage: SuperChems, ASPEN, HTRI, AFT ARROW, AFT Fathom.Addition Required Qualifications/Job Requirements:Master’s or bachelor’s degree in chemical engineering from accredited university or college.Understand process flow diagrams, piping and instrumentation diagram and equipment layouts, conceptual equipment layouts, process layout, utility layout and other block layouts.Understand Plant process design with equipment sizing & utility load design calculation. Must have strong interpersonal, communication, collaboration, and consultation skills. This position will interact with personnel in all organizations.Ability to organize, prioritize, and execute a heavy workload simultaneously within budget and schedule.Must have the ability to communicate effectively through verbal and written means, and able to adapt communication to best reach the intended audience within or outside the organization.Strong customer focus, with demonstrated ability to solve complex issues and work in partnership with peers, Manufacturing, and other stakeholders.Ability to compile and analyze complex data.Knowledge in application of industry standards, recommended practices, and codes (API, NFPA, ASME, etc.)Ensure regulatory compliance of process changes- Provide and communicate clear, concise, and timely reporting of project progress and accomplishments verbally and in writing. 

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Process Equipment Engineer

Chemical Engineer – Relief Systems Process Safety

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Process Equipment Engineer

Chemical Engineer – Relief Systems Process Safety

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