This position will be part of DP engineering team under WuXI STA, the role will design, develop, optimize and maintain as system owner the manufacturing automation system at Middletown, Delaware site.  This may include systems on building automation, process automation and other digital systems through pharmaceutical drug products manufacturing and packaging platforms.  The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.

• Lead to develop and establish manufacturing site automation strategy, define execution plan and implement under overall site expansion plan.
• Acting as a key role of automation system owner, lead to identify, design, build and verify system to comply with all relevant requirements. Cooperate with other function team to ensure overall system delivery,

• Design and establish a complete lifecycle management procedures and instructions to manufacturing automation systems, Implement and maintain the systems to ensure its reliable operation status and compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations.

• Lead and implement Computerized System Validation and its maintenance, upgrade and retirement over whole lifecycle at process equipment automation areas.
• Participate in Sterile manufacturing, OSD manufacturing and lab system project as automation SME to ensure successful realization of state-to-the-art technologies,
• Leads 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.
• Assists with preparation and maintenance of User Requirements Specifications.
• Hands-on experience with troubleshooting and resolving process equipment automation-related issues during production.
• Lead managing automation maintenance, calibration and reliability programs independently with minimum supervision.
• Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs.
• Writing Change Controls, Investigation reports, Work Orders, CAPA, Standard Operating Procedures (SOP), and risk assessments.
• Analyzing process data and driving continuous improvement initiatives to enhance efficiency, reduce costs, and improve product quality.
• Providing technical support and training to production staff on new processes automation, equipment, and safety protocols. 
• Identifies and proposes process automation improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution.
• Facilitate communication across internal and external partners/collaborators to ensure timely tasks completion at whatever project phase and operation phase
• Plan and manage budget at site automation scope.
• Performs other related duties as assigned.

• 3 - 5 years of experience in a Process Equipment or building automation role, preferably in the pharmaceutical drug products manufacturing industry.
• Knowledge on cGMP and CSV related regulation requirements, ability and experience on pharmaceutical process automation system, DCS or other PLC control system, Database structure and its operation, maintenance, Cloud system data flow and its control, monitoring and maintenance.
• Bachelor’s degree in Engineering (preferably in Mechanical, Electrical or Chemical Engineering).
• Thorough understanding of cGMP and FDA requirements
• Strong communication and documentation skills
• Proven project management skills
• Experience with equipment qualification following ISPE and ASTM guidelines.
• Proficient with Microsoft Office Suite, Maximo, Calibration program software, MES, etc.

Skills:

• Technical: 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.
• Analytical & Problem-Solving: Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions.
• Soft Skills: Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills.
• Industry Specific: Familiarity with FDA regulations, cGMP guidelines, Lean Manufacturing, and risk assessment techniques (HAZOP, FMEA). 

Preferred:

• Prior experience as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing process and packaging equipment.
• Familiarity with Sterile F/F equipment qualification is a plus.
• Familiarity with IOQ/PQ of process/packaging equipment for the pharmaceutical industry.
• Familiarity with Maximo or equivalent Regulatory Asset Manager software.