Nesher Pharmaceuticals (USA) LLC
  • 25-Jan-2018 to 26-Mar-2018 (CST)
  • Operations - Engineering
  • St. Louis, MO, USA
  • Full Time

Competitive Benefits Package


summary

Oversee department specific operations, to include Process Equipment Sourcing, Equipment maintenance, preventive maintenance, calibration, project engineering, and Process room planning.    

 

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.
  • Ensure quality and safety standards are met, and the maintenance and calibration operations are efficient and organized.
  • Maintain Process Equipment in highest level of compliance to ensure operating procedures and maintenance work orders are executed in accordance with all regulations.
  • Prepare URS, source various Equipment suppliers, source and purchase equipment.
  • Manage process equipment projects as required, ensuring that deliverables are met on time and within budget.
  • Provide direct supervision and coaching to front line employees and promote an open and collaborative work environment.
  • Provide expectations to employees and ensure all necessary resources are available for employees to perform at highest safety and quality levels.
  • Prepare and communicate operational objectives to achieve site and department strategy, specifically around quality, safety and operational efficiency.
  • Review operating staff performance regularly and develop individuals within operating functions to continually enhance individual and overall work team performance.
  • Establish consistent work instructions.
  • Promote an open and collaborative work environment with all peers and subordinates.
  • Identify and implement continuous improvements such as, but not limited to, equipment reliability.
  • Develop and provide periodic reports on operating metrics and improvement initiatives.
  • Supervise assigned PMs /Calibrations activities with outside contractors/tradespersons as required.
  • Deploy reliability FMEA Engineering Program.
  • Ensure maintenance of CMMS
  • Periodically conduct GMP compliance audits for Process Equipment.
  • Develop Robust PM programs based on Equipment life cycle.
  • Conduct root cause and problem solving investigations related to Process Equipment.
  • Follow maintenance work request and other applicable procedures. Provide internal customers with pertinent information regarding method and scheduling of repairs, project updates, calibration and PM status of equipment/instruments. Monitor reports of outstanding requests and set priorities on all pending requests and schedule activities accordingly.
  • Coordinate routine and emergency maintenance of process equipment. Maintain up to date schedule of all routine maintenance and descriptions of required work. Ensure all maintenance is completed properly and on time, and that a record of completion is kept.
  • Requisition repair materials, equipment, and services as required for the maintenance of equipment /Calibration. Compare vendor / supplier prices of frequently purchased items to ensure best price and delivery. Monitor stock inventory of frequently used spare parts to minimize delivery costs and avoid production downtime.
  • Work on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercise judgment within defined procedures and policies to determine appropriate action. Act as an advisor to a unit or sub-units, become actively involved as required to meet schedules and resolve problems.
  • Receive assignments in the form of objectives with goals and processes to meet goals outlined. Provide guidance to employees according to established policies and management guidance.
  • Administer company policies that directly affect subordinate employees. Recommend changes to unit or sub-unit policies.
  • Write purchase requests and obtain competitive bids on jobs performed by vendors/tradespersons.
  • 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

  • Thorough understanding of cGMP regulations and requirements and ability to translate to operational details and communicate to work staff.
  • Knowledge of all utilities those are required for efficient operations of process equipment, including related OSHA and Pharmaceutical cGMP regulations.
  • Reliability Engineering programs.
  • Demonstrated leadership and coaching skills, including interpersonal and organizational skills with ability to coach and mentor personnel to consistently high standards.
  • Effective oral and written communication skills.
  • Demonstrated problem solving skills in identifying and resolving issues.
  • Experienced in and/or knowledgeable of machine controls and PLC.
  • PC proficiency using Microsoft Office suite.
  • Familiarity with CMMS/CCMS (for PMs/calibrations, comfortable with equipment documentation, drawing updates, etc., to keep system current).
  • Ability to execute tactical plans and maintain established timelines and budgets.
  • Ability to develop and maintain strong working relationships with primary support functions.
  • Ability to read, comprehend and execute Standard Operating Procedures (SOPs) and instruction documents written in English.

 

EDUCATION/EXPERIENCE

  • Mechanical / Electrical / Electro Mechanical Engineering Bachelors' degree and minimum of five years' pertinent and progressive experience in pharmaceutical manufacturing or other highly regulated industry.
  • Five years' supervisory/leadership experience in production area of pharmaceutical, chemical, food or other highly regulated industry.
  • Added qualifications such as Six Sigma Black Belt and /or Project Management Professional (PMP) are preferred.
  • Experience in automation/MES packages for controllers of Rockwell and Siemens.
  • Experience in P&ID's, Process Flow diagrams.

 

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, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
  2. 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 and/or up to 50 pounds of force rarely by utilizing a hand truck 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. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
  2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
  3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
  4. 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.

 

Nesher Pharmaceuticals (USA) LLC
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