Process Engineer II
Piramal Glass USA
Kentucky

About $78,000 - $100,000 a year

EducationSkills
Process Engineer II - (190000W0)
Description

POSITION SUMMARY

  • To design and efficiently transfer new processes into manufacturing, to optimize existing processes, and ensure that production goals in terms of quality, yield, capacity, and timelines are met.
  • Drafts Experimental, Development, and Operational Studies to expand expertise in parenteral manufacturing.
  • Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
  • Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
  • Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment.
PRIMARY RESPONSIBILITIES

  • Relies on limited experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks.
  • Works under general supervision.
  • A certain degree of creativity and latitude is required.
  • Develops processes and implements improvements related to new and existing products.
  • Leads development activities, experiments, startups, etc.
  • Take initiative to develop and improve procedures and setups through the change control process.
  • Prepares and reviews technical documents to include but not limited to: Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols.
  • Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
  • Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
  • Maintains awareness of current developments in the functional discipline. Develops a network of outside contacts such as vendors, consultants, educators and appropriate continuing education courses.
  • Reviews current and new processes; applies state-of-the art technology to our processes.
  • Coordinate line activities with other functions such as maintenance and downstream manufacturing events.
  • Recommends, justifies, demonstrates and implements new manufacturing technologies as they become available.
  • Maintains documentation on all projects and submit written reports in a timely fashion.
  • Interfaces with other operating units within and outside the department. Presents ideas and suggestions for product and/or process, equipment improvements, improved Laboratory and Manufacturing operations.
  • Train Manufacturing staff on new processes and/or equipment technologies.
  • Ensure efficient operations in assigned project areas in accordance with OSHA Safety Requirements, SOP's and GMP's. Ensures functional operation and preventative maintenance of equipment to reduce/eliminate accidental injury.
  • Interacts with external vendors.
  • Independently plan and organize non-routine tasks. Initiates and maintains work schedule. Follow-through on priorities of work assignments.
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
WORK ENVIRONMENT

  • 60% Computer/office work.
  • 40% in a clean room or laboratory environment.
  • Position may require extended hours including evenings and weekends, travel between multiple work sites.
Qualifications

QUALIFICATIONS

  • B.S. + 2 – 5 years experience, M.S. + 0 – 3 years experience in Mechanical or Chemical Engineering or similar. 0 to 5 years related experience and/or training; or equivalent combination of education and experience.
  • Familiar with standard concepts, practices, and procedures within the field.
  • Knowledge of pharmaceutical parenteral manufacturing principles and packaging equipment.
  • Awareness of regulatory guidelines and requirements.
  • Ability to work independently on a cross-functional team which may include operations, quality assurance, validation, and laboratory.
  • Effective at collaborating with others to obtain the desired organizational objectives.
  • Good listening skills
  • Good oral and written communication skills, especially with external interactions.
  • Able to handle multiple complex tasks and follow priorities with multiple internal customers.
  • Strong working knowledge of MS Excel, Word, and Visio, including formulas and graphing functions.
  • Experience in process development and scale-up desired.
Primary Location: United States-Kentucky-Lexington
Work Locations: Lexington 1500 BULL LEA ROAD, SUITE 250 Lexington 40511
Job: Technical Services
Organization: Pharma Solutions
Day Job
Job Posting: 10-Apr-2019, 7:45:41 AM