WuXi AppTec · 2 weeks ago
Director of Engineering – Drug Product
Middletown, DE
Full-time
Onsite
Director/Executive
15+ years expWuXi AppTec is constructing a new Greenfield CDMO facility to manufacture finished drug products. They are seeking an experienced Director of Engineering to manage capital project engineering and lead the development of investment plans while ensuring compliance with safety and quality standards.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Overall responsible for capital project engineering management in Middletown over the whole project lifecycle, includes business strategic planning and site master planning, Risk assessment, Design management, budget establishment & control, procurement, construction management, schedule, safety management, process, commissioning & qualification per GMP/FDA compliance
Own the development and delivery of the capital investment plan in accordance with the site objectives for new products and facility modernization
Lead and Implement CAPEX investment project and expansion through inputs by business case study, financial analysis and feasibility study
Ensure that engineering activities are performed to plan and to policy (safety, schedule, quality, cost)
Ensure the systems are in place and executed to establish the initial qualified and safe state for equipment, processes, utilities and facilities
Ensure equipment, processes, utilities and facilities system are in place and executed to establish the initial qualified operate, maintenance, calibration and safe state
Ensure that equipment maintenance/calibration and utilities operation are performed and documented to the highest standards of safety and quality
Notify management of issues with equipment, processes, utilities and facilities that could have an impact to product or to the employees and persons within the site
Ensure all technical and administrative processes ensure compliance and also are continuously improved
Develop local processes and procedures at engineering scope in accordance with the STA global management system
Assure an adequate number of qualified resources to perform asset engineering management processes
Manage and contribute in STA global engineering team for Project standardization and uniformity, establish global guidelines in pharmaceutical DS/DP R&D and manufacturing facility design/construction/C&Q process
Manage the site investment processes for assets (planning, prioritization, resourcing, project management, capital accounting and reporting)
Manage by the company values of Integrity, Excellence and Respect for People
Develop and coach personnel capability to meet business needs(technical and managerial)
Manage resources accordingly to site priorities & anticipate future business needs
Develop and adapt organizational structure for the technical direction to provide correct and capable resources and management to deliver the site engineering
Promote continuous improvement culture across site (strive for excellence)
Have external focus, benchmark best practices across network and external
Qualification
Required
Minimum bachelor degree, Major in Engineering background, with more than 15 years of engineering experience in a Drug Product manufacturing operation, parental drug product background is a plus
Demonstrate Safety First through own proactive action/ commitment across business area, and expect and coach subordinate to do likewise. Ensure conformance to EHS expectation on performance (including fire safety)
Working knowledge of manufacturing and R&D operation
Strength in handling with local codes and regulations while maintaining international standards
Good acknowledge of GMP/FDA/ICH and implementation
Strong teamwork spirit
Strong communication and partnering skills
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
2026-01-15
2026-01-14
South China Morning Post
2026-01-14
Company data provided by crunchbase