Process Equipment Engineer

divh2DP Engineering Team Position/h2pThis position will be part of DP engineering team under WuXI STA. The role will design, develop, optimize and manage execution the whole lifecycle activities of GMP drug product manufacturing and packaging process including equipment at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed./ph3Responsibilities/h3pThe role will be responsible for managing and executing the site manufacturing equipment project and its lifecycle management./ppBe part of project team as manufacturing system owner, lead to identify, design, supervise and verify manufacturing system to meet process development, production and EHS requirement, and comply with all relevant regulation./ppLead to develop and establish programs for OSD/Sterile manufacturing system and other assigned system maintenance and calibration plan and manage execution, included but not limited on the system documentation, operation resources, technical services, training and material planning etc./ppLeads cross functional teams in completion of system impact evaluations and system risk assessments in a multi-product facility. Performs gap assessments and remediates new risks as new equipment and/or products are introduced./ppEnsuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations./ppConducting risk assessments and supporting equipment/utilities qualification activities./ppHands-on experience with troubleshooting and resolving process equipment-related issues during production./ppExperience managing equipment Preventative maintenance, Calibration, and reliability programs independently with minimum supervision./ppExperience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must./ppExperience in packaging equipment like bottles packaging, blisters packaging, powders packaging, etc./ppCollaborating with cross-functional teams, including RD, Quality Assurance, Production, and Regulatory Affairs./ppExperience in writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments./ppAnalyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality./ppProviding technical support and training to production staff on new processes, equipment, and safety protocols./ppIdentifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution./ppPerforms other related duties as assigned./ph3Qualifications/h3p3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry./ppAbility to read and understand engineering drawings such as PIDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications./ppBachelors degree in Engineering (preferably in Mechanical, Electrical or Chemical Engineering)./ppThorough understanding of cGMP and FDA requirements/ppStrong communication and documentation skills/ppProven project management skills/ppExperience with equipment qualification following ISPE and ASTM guidelines./ppProficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc./ppstrongSkills:/strong/ppTechnical: Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software. Knowledge of cGMP guidelines and regulatory compliance is essential./ppAnalytical Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions./ppSoft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills./ppIndustry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA)./ppstrongPreferred:/strong/ppPrior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing process and packaging equipment./ppFamiliarity with Sterile F/F equipment qualification is a plus./ppFamiliarity with IOQ/PQ of process/packaging equipment for the pharmaceutical industry./ppFamiliarity with Maximo or equivalent Regulatory Asset Manager software./p/div

Created: 2026-03-04