Director of Engineering – Drug Product

WuXi AppTec•Middletown, DE

13d

About The Position

Overview STA Pharmaceuticals is constructing a new Greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. To support the detailed design, construction, CQV activities, and start-up of the new facility, we are seeking an experienced Director of Engineering 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. 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. Management and organization 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

Requirements

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

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