About The Position

Organize all activities within the Compounding department related to the batch making equipment. The mission is to achieve the highest levels of safety, service, quality, equipment reliability and productivity. Actively participate in engineering work and provide technical support, knowledge and guidance at the floor level.

Requirements

  • BA/BS in Engineering preferred but not required
  • Background with cGMP and FDA compliance preferred.
  • Demonstration of strong detail orientation, organizational skills and the ability to work independently and multi-task.
  • Proficient in Word, Excel and Outlook
  • Must be self-motivated and initiate continuous improvement.
  • Previous experience in a similar position or multi-year experience in the Manufacturing Engineering area.
  • LICENSE OR CERTIFICATION REQUIRED: Forklift, Aerial Lift

Nice To Haves

  • Preferred experience with oil and gas, chemical plant, mixing and process of liquids/solids, food & beverage or similar

Responsibilities

  • Adopts and drives Lean Manufacturing principles and other continuous improvement methods that improve processes, overall equipment effectiveness (OEE), Process Reliability (PR) defect rates, safety rates, and cost targets
  • Develops and/or refines Standard Operational Procedures (SOPs), including LOTO, Process Safety Management (PSM), NFPA 70E and 79. Ensures compliance with all relevant procedures, practices, regulations and policies to maintain the highest level of safety for all employees. Schedule Compounding personnel for all direct and indirect Compounding assignments, overtime, and rework.
  • Creates and distributes reports to teams and upper management detailing the progress and status of actions, including delays, scope changes and cost escalation
  • Performs all work in a manner that is consistent with the company’s quality system and FDA good manufacturing practices, including always maintaining a clean and orderly production area.
  • Coordinates and participates in root cause analysis on PR/OEE shortfalls. Develops and executes corrective actions that improve equipment performance, cost, quality, and customer service
  • Follows, promotes, and enforces KDC’s safety and environmental policies, practices, and procedures.
  • Perform daily surveillance of all Compounding areas to identify safety or quality risks and implement action plans to address any risks found.
  • Assists with safety investigations and corrective actions related to safety hazards and/or incidents.
  • Contributes to the training plan and drives the execution of training to ensure all production employees have received necessary training and are following all applicable SOP’s, Work Instructions, and GMP procedures.
  • Supports the development and execution of robust systems to improve the operation and asset utilization. Reducing unplanned downtime to the minimum possible. Investigate with Compounding Leaders and complete accident/incident reports with employees.
  • Available to support business needs over the phone, Microsoft Teams or in urgent cases on-site of off normal admin hours.
  • Perform other duties as requested by the Compounding Manager.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Number of Employees

5,001-10,000 employees

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