*Leads site based project engineers (internal and external) in the execution of Capital investment projects at specified manufacturing site.
*Accountable for Capital projects to be delivered on schedule and budget and to meet customer / business requirements.
*Responsible to drive site based project managers to exhibit leadership and ownership of Capital projects from concept to completion of first lot to stock / licensure.
*Integrates cost reduction, best project management skills, and ongoing execution improvement into capital projects.
*Partner with other site based engineering and project management staff.
*Responsible for partnering with Safety organization to ensure proper safety programs are in place and effective (meet corporate goals).
*Manages engineering work in progress to insure that there is adequate interface and coordination with various regulatory groups to insure compliance with Safety, Quality Assurance and Environmental Control regulations and policies.
*Consults on the engineering design of new facilities, processes, and equipment for compliance with Global standards and FDA regulation and federal law.
*Key participant in the preparation of the Capital Plan from concepts to budgetary estimates.
*Provides engineering input into long-range planning efforts for key products, processes and long-range development of manufacturing initiatives.
*Continuously benchmark facility and equipment technology world-wide to assure that statistically competent, competitive and high quality manufacturing process are implemented.
*Through continuous evaluation of pharmaceutical facility trends worldwide, assures that the technical expertise within remains world class. Identifies gaps in expertise and develops plans to upgrade skills of current project management personnel or develops plans to recruit personnel with necessary skills.
Desired Candidate Profile
UG: Any Graduate - Any Specialization, Graduation Not Required
PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
A minimum of 8 years experience is preferred.
Experience in Project Management for Green Field / Brown field projects.
Good technical experience in Sterile Injectables.
Regulatory environment experience.
Project management, cost estimating, scheduling, and people management experience are required.