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Summary: Responsible for providing key leadership, direction, organization, management, monitoring and cGMP compliance of the roles, activities and proceedings of all assigned Engineering personnel in order to ensure the successful, cost effective, timely and safe project and implantation of “systems”.
Essential Duties and Responsibilities:
• Manages and directs the employees and functions of the Engineering Department to include design, justification, installation, maintenance and disposal of equipment for facilities, production and utilities.
• Manages all operational aspects of the area including productivity, cost, continuous improvement and daily business processes.
• Insures compliance with all applicable corporate and regulatory SOP, cGMP, and safety guidelines.
• Insures all personnel receive necessary and appropriate training for their job function.
• Effectively manages employee relations including hiring, discipline, rewards and recognition, and effective human capital resources allocation.
• Participates and represents Company in FDA audits and inquiries.
• Develop and achieve annual budget for Operations Supervisory Responsibilities:
Manages All Mechanical and Automation Engineering/Electricians/PLC personnel CAD operations and Reliability as well as outside contractors.

Education and/or Experience:
BS degree in Engineering. Has had significant engineering experience in Manufacturing, Operations, and Business. 7 years of pharmaceutical experience. 5 years in aseptic processing
Language Skills:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write clearly.  Ability to speak effectively.  Mathematical Skills:
Ability to apply basic math concepts. Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Computer Skills:
Proficient in the use of MS Word, Excel, Outlook and Access, as this individual will perform work within these systems on a routine basis.
Other Skills and Abilities:

• Excellent Communication skills, both verbal and written
• Ability to organize time in order to successfully manage multiple projects and priorities
• Ability to read, understand, interpret and implement technical writing and instructions.
• Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
• Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
• Must possess and demonstrate knowledge and experience in cGMPs and relevant Safety Regulations (e.g., OSHA).
Other Qualifications: Must pass background check Must pass drug screen
Physical Demands: While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

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