DP Engineering Lead Sterile

WuXi AppTec

About The Position

STA Pharmaceuticals is constructing a new Greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware.To manage deliver the manufacturing system engineering, construction, CQV activities, start-up and operation of the new facility, we are seeking an experienced senior level of engineering lead to join our highly skilled team. As an ideal candidate, you will have proven senior management experience in a highly dynamic setting. Your organizational, communication, and leadership skills will help us develop solutions that push innovative boundaries. You will work closely with executives to strategize and develop long-term plans that usher in new levels of productivity and success at STA Pharmaceuticals. This position will be a key contributor in the initial construction phase and play a key role in the transition process to operationalize the site throughout year 2026/2027 onwards. Per individuals’ strength and personal development, this position will be further transitioning into the role in operation and technical team leader with management responsibility.

Requirements

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

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