WuXi AppTec · 9 hours ago
Manufacturing Automation Engineer
Middletown, DE
Full-time
Onsite
Mid, Senior Level
3+ years expWuXi AppTec is a company focused on pharmaceutical manufacturing and packaging solutions. They are seeking a Manufacturing Automation Engineer to design, develop, and maintain automation systems at their Middletown, Delaware site, ensuring compliance with quality standards and regulatory requirements.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
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
Qualification
Required
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
Strong understanding of engineering principles, process design and optimization, quality control, pharmaceutical manufacturing technologies, equipment, and relevant software
Ability to analyze complex processes and data, identify bottlenecks, troubleshoot issues, and develop effective solutions
Excellent communication (written and verbal), teamwork, leadership, project management, organizational abilities, time management, adaptability, attention to detail, critical thinking, and negotiation skills
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
Company
WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical.
10001+ employees
H1B Sponsorship
WuXi AppTec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
2021 (1)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.59BKey Investors
Eight Roads Ventures
2025-03-03Acquired
2018-05-08IPO
2016-03-06Debt Financing· $1.5B
Leadership Team
Ge Li
CEO
Recent News
Morningstar.com
2026-01-19
2026-01-15
2026-01-14
Company data provided by crunchbase