Nesher Pharmaceuticals (USA) LLC

Director, Engineering and Maintenance Jobs at Nesher Pharmaceuticals (USA) LLC

Director, Engineering and Maintenance Jobs at Nesher Pharmaceuticals (USA) LLC

Sample Director, Engineering and Maintenance Job Description

Director, Engineering and Maintenance

Summary

Plan and direct company engineering and maintenance projects.  Provide proactive administrative and technical leadership on all capital projects. Foster innovation and execute engineering and maintenance strategies to meet business objectives and regulatory compliance.  Organize and ensure alignment of facility and engineering functions to overall company needs.  Maintain overall project execution, timelines, and spending while adhering to all quality and construction regulations.  

Essential Duties and Responsibilities

  • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to the plant working groups.
    • Plan, organize and direct project and facility engineering and maintenance activities and programs relating to the improvement of company operations, including the evaluation, justification and execution of capital projects. 
    • Assist with the planning, technical execution and implementation of major complex capital programs, as required, to achieve business objectives.
    • Ensure compliance with all governmental, state and local regulations.
    • Develop and maintain Facility Use Master Plans to ensure an organized approach for organizational growth and usage of company assets.
    • Facilitate the development and continuity of effective teamwork toward achievement of the Company business plan.  Develop a climate conducive to trust, open communications, mutual goal setting, recognition and equitable economic rewards.
    • Assist with the planning, development and implementation of capital spending, engineering, and maintenance strategies required to meet company objectives.
    • Tracks and complete capital projects while meeting all schedule and budget requirements.
    • Identify, lead, and implement Continuous Improvement projects.
    • Maintain effective and cooperative relationships with all departments, especially Quality and R&D, to ensure the concerns of Operations are recognized in the early stages of product development.
    • Ensure the participation of project and facility engineering and maintenance personnel in the selection, testing and evaluation of new processes and equipment. 
    • Provide engineering and maintenance expertise and assistance in the start-up and validation of systems and equipment.
    • Identify facility and equipment projects, develop project scope, prepare preliminary estimates, refine project scope, and direct installation of projects.  Assist with the development of layouts for operational and R&D processing, warehousing operations, plant utilities, and other facilities as required.
    • Develop, negotiate and execute construction and other capital related contracts and purchases.
    • Maintain knowledge of current developments relating to new processing, packaging, warehousing equipment and procedures in order to make recommendations concerning appropriate utilization for the purposes of producing a superior product or package at a lower cost.  Develop methods, investigate and recommend equipment.
    • Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations.
    • Assist others in the organization to provide experience and expertise where consultation is requested or required.
    • Maintain accurate working knowledge of governmental/regulatory requirements as related to equipment including EPA, DEA, OSHA, and the FDA.  Monitor and ensure company compliance with regulatory standards.  Accompany agency representatives or inspectors as required.  Respond to infractions.
    • Develop and submit annual capital budget.
    • Develop annual engineering and maintenance expense budgets for the facilities.  Monitor monthly engineering and maintenance costs against budgeted amounts to identify opportunities for better cost control.
    • Develop policies and authorize the implementation of these policies. 
    • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
    • Perform other related duties as assigned to meet departmental and company objectives. 

KNOWLEDGE/SKILLS/ABILITIES

  • Knowledge of and compliance with CGMP, departmental and company policies, as well as other regulatory requirements such as OSHA, DEA and EPA.
  • Highly organized with proven project management, financial and negotiation skills to effectively manage multiple priorities, projects and requirements in a fast paced, dynamic environment.
    • Proven leadership and interpersonal skills to effectively lead, influence, collaborate, and work with diverse teams and individuals at all levels throughout the organization.
    • Demonstrated technical proficiency, scientific creativity, and independent thought.
    • Demonstrated expertise in the core methods and tools of Project Engineering, with proven success in delivering business results using improvement tools.
    • Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
    • Ability to solve manufacturing, packaging or facility related problems either individually or in conjunction with a team by using problem solving skills, designs of experiment and statistical analysis in a timely and cost effective manner.
      • PC proficiency using Microsoft Office suite, including MS Project.
      • Familiarity with AutoCAD. 

EDUCATION/EXPERIENCE

  • Master's degree in engineering or related technical discipline; or the equivalent in related education and pertinent and progressive experience, with increasing levels of responsibility.
  • Fifteen years' experience in engineering field.
  • Fifteen years' pharmaceutical experience or other highly regulated industry.
  • Six Sigma Black Belt and/or Lean Manufacturing certification desired. 

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  1. Stand, walk, sit, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk, and hear.
  1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  1. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects. 

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  1. Individual is in a proximity to moving mechanical parts and exposure to chemicals.
  2. Individual may be required to wear respiratory devices that include but are not  limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

We are an equal opportunity employer M/F/D/V.

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