WuXi AppTec · 1 day ago
Process Engineer
Middletown, DE
Full-time
Onsite
Mid Level
3+ years expWuXi AppTec is a leading global pharmaceutical and biotechnology company, and they are seeking a Process Engineer to design, develop, optimize, and support GMP drug product manufacturing and packaging processes. The role involves ensuring compliance with quality standards and regulatory requirements while collaborating with cross-functional teams to enhance efficiency and product quality.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Implementing and maintaining manufacturing process automation and control systems
Participate as a member of 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 the preparation and maintenance of User Requirements Specifications
Ensuring compliance with regulatory requirements (FDA, EMA, cGMP), quality standards, and safety regulations
Conducting risk assessments and supporting equipment/utilities qualification activities
Hands-on experience with troubleshooting and resolving process equipment-related issues during production
Experience managing equipment, Preventive Maintenance, Calibration, and reliability programs independently with minimum supervision
Experience with OSD equipment but not limited to Wet Granulation systems, Bin Blenders, Encapsulation, Tablet Presses, Tablet Coaters, Roller Compactors, etc. is a must
Experience in packaging equipment like bottle packaging, blister packaging, and powder packaging
Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs
Experience in 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, equipment, and safety protocols
Identifies and proposes process improvement ideas and collaborates with cross-functional teams to meet project deliverables and timelines, including scheduling, testing, and deviation resolution
Performs other related duties as assigned
Qualification
Required
3 - 5 years of experience in a Process or Equipment engineering role, preferably in the pharmaceutical drug products manufacturing industry
Ability to read and understand engineering drawings such as P&IDs, equipment/facility layout drawings, electrical/pneumatic drawings, and functional specifications
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
Bachelor's degree in engineering (Mechanical, Electrical, Industrial) or a related field
3-5 years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment
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
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 processes and packaging equipment
Familiarity with Sterile F/F equipment qualification is a plus
Familiarity with the IOQ/PQ 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
Founder, Chairman and CEO
Recent News
2026-01-03
MarketScreener
2025-12-22
Company data provided by crunchbase