WuXi AppTec · 5 hours ago
DP Engineering Lead Sterile
Middletown, DE
Full-time
Onsite
Senior Level, Lead/Staff
15+ years expWuXi AppTec is constructing a new Greenfield CDMO facility in Middletown, Delaware, and they are seeking a Senior DP Engineering Lead to manage the manufacturing system engineering and construction activities. This role will be pivotal in the initial construction phase and will transition into operational leadership, ensuring compliance and innovation in sterile injectable products manufacturing.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Overall responsible for drug products manufacturing system engineering management in Middletown project 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 manufacturing system in accordance with the site objectives for new products and facility modernization at areas of sterile injectable products manufacturing and packaging but not limited to
Responsible leading the collaboration of the different external and internal partners to ensure the manufacturing process engineering meets the operational intent of the project while driving innovation by identifying and evaluating new technology opportunities
The individual will be responsible for interacting with the partners across global sites to ensure the process trains be set in appropriate way to meet defined requirements on process and products
Collaborates with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process design, commissioning, qualification, and validation documentation is reviewed and approved
Lead develop and ensure equipment, processes, utilities and facilities system are in place and executed to establish the initial qualified operate, maintenance, calibration and safe state
Lead develop and ensure the manufacturing process, material specs and planning, operation procedure and instructions, people training and qualification are in place and executed to establish an effective and efficient operation state
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, lead and continuously improve the DP process engineering organization including developing required capabilities, process, technical system and tools in supporting DP business growth
The individual will keep close cooperation with the Site Leadership Team and will support the creation of a culture that aligns with the Company’s core values of integrity & dedication, working together, doing the right thing, and doing it right
Manage and contribute in STA global engineering team for products and process platform standardization and uniformity, establish global guidelines in pharmaceutical DS/DP R&D and manufacturing facility design/construction/C&Q process
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 Pharmaceutical and or Engineering background, with more than 15 years of 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
Language: English: Fluent
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