Principal Project Engineer

Summary

Develop and execute improvement projects within the operations and supply chain functions.  Maintain daily interaction with operating groups to drive project implementation and track ongoing success against completed project tasks.  Actively lead teams and provide individual contribution to problem solving efforts on selected facility and equipment projects to improve quality, reduce cost and improve processing cycle times.  Collaborate with Operations, Quality and R&D to implement and integrate identified projects to meet timelines and targeted results.  Implement best practice mindset within work functions and function as key change agent for business system improvements.  Mentor personnel and assist in guiding activities to successful completion.  

Essential Duties and Responsibilities

• Provide a systematic approach to solving plant problems by utilizing technical expertise.
• Visualize what options are available and then develop alternative solutions, action plans and cost estimates to build and or modify systems that will correct the problem.
• Prepare detailed proposals and Capital Expenditure Appropriation (CEA) forms for management approval. 
• Prepare project timelines and resource plans.  Track progress against those plans and timelines.
• Interface with all areas of the plant and at times all levels of management.
• Responsible to stay within the developed CEA budget and maintain accurate record keeping of CEA expenditures to ensure proper financial management of projects.
• Complete assigned projects in allotted time, monies and with minimum alterations and revisions.
• Prepare reports on progress of projects on a periodic basis.
• Manage up to 10 projects simultaneously in different stages of development and execution.
• Normally receive little to no instruction on routine work, and general instructions on new assignments.
• Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Work on complex problems in which analysis of situations or data requires an in-depth evaluation of intangible factors.  Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Act independently to determine methods and procedures on new assignments.  May oversee and manage the activities of other personnel – primary role is an individual contributor.
• Identify and lead the implementation of continuous improvement opportunities.
• 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 NEC, OSHA, DEA and EPA.
• Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
• Demonstrated expertise in the core methods and tools of Project Engineering, as well as the proven ability to deliver business results using all improvement tools.
• Excellent interpersonal and communication skills to effectively work with an array of different departments and outside vendors.
• Proficient in Microsoft Office suite, including MS Project.
• Familiarity with AutoCAD.
• Ability to solve manufacturing, packaging or facility related problems either individually or in conjunction with a team by using problem solving skills, design of experiment, and statistical analysis in a timely and cost effective manner.
• Ability to manage any project scope and capital spend. 

EDUCATION/EXPERIENCE

• Master's degree in engineering, business or related technical discipline; or a Licensed Engineer with the equivalent in pertinent and progressive experience, with increasing levels of responsibility.
• Ten years' experience in engineering field.
• Ten years' pharmaceutical experience or other highly regulated industry. 

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.

3. 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.

Current Openings for Principal Project Engineer Jobs at Nesher Pharmaceuticals (USA) LLC