Posted 2 years ago in Engineering
Join leading healthcare company and be responsible for the direction of engineering technology and support of facility, utility and equipment qualification functions of the company. Looking for someone with Process and/or Product Engineering experience.
RESPONSIBILITIES include overseeing the development and implementation of the engineering technology needs. Work with Global QA group and engineering functions to ensure methods are compliant with current GMP's. Manage engineering document systems, capital construction projects, budgets and engineering staff for equipment installation. Provide engineering support to the Manufacturing, Packaging, and Research & Development (R & D) departments for all sites. Coordinate and direct the activities and functions of engineering projects. Participate in the selection, purchase and design of pharmaceutical equipment as needed and assists and facilitates the installation of equipment for the plant. Monitor the project-detailed design to assure compliance within guidelines and standards.
Seeking someone with knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. Knowledge of pertinent federal, state and local laws, codes and regulations. Knowledge of GMP, SOP, FDA, OSHA and other applicable standards, guidelines and regulatory requirements for pharmaceutical industry is required. Knowledge of principles and practices of project management, budgeting and contract administration, facility planning, construction and building maintenance are required.
Must possess the skills needed to implement goals, objectives and practices for effective, efficient and cost effective management of allocated resources. Excellent communication skills - able to present to top management, public groups and/or boards of directors.
Looking for a minimum of a Bachelor's degree (or equivalent) and 5 years of experience. 8-10 years of engineering/management experience, in a pharmaceutical industry; manufacturing and packaging experience needed; Professional Engineer (P.E.) certification in state of plant operation is preferred. Periodic travel is required. Global experience preferred. KEY is able to handle multiple projects at one time, able to influence others, strong packaging exp, ability to manage technical individuals. Looking for someone with oral solid dosage, injectible/sterile, biologics and/or respitory.
Relocation available for right candidate.
Specializing in mid-level staffing solutions that builds the foundation for future leadership within an organization. The firm supports the search process by providing both full-time executives and consultants to clients using the same care that JBK Associates devotes to senior-level retained searches.
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