Title: Process Development Engineer

Job Summary

Perform product development, process improvement, scale-up and validation activities as mandated by cGMPs policies/procedures and the company’s quality standards. Assist operations and quality units as necessary. Monitor technicians, operations and quality personnel during development, validation and scale-up activities, as necessary. Under limited direction and supervision assist in scale-up, technology transfer projects by designing and writing batch manufacturing records, protocols, preparing FMEA execution, writing summary reports and trouble shooting.

 

Responsibilities

ESSENTIAL DUTIES

  • Responsible for driving all aspects of project planning and material ordering
  • Execution of experimental batches, creating batch manufacturing record and FMEA creation and follow up through approval documents
  • Evaluation of experimental batches data and providing primary conclusion
  • Author, review, revise, or approve SOP’s or other documents as required
  • Interface with manufacturing, packaging, logistics and engineering to facilitate and drive documents review and approval
  • Provide support for scale-up, technology transfer and commercial projects
  • Follow cGMP’s, safety procedures, DEA procedures, department SOP’s and company policies
  • Participate on cross-functional teams that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
  • Assist department in other assigned functions as required
  • Prepare protocols, manufacturing batch records, ensure sampling and testing are completed as planned, executing manufacturing batch records and evaluate all in-process and analytical data and write reports
  • Coordinate cleaning and manufacturing activities with company quality units, operations, R&D, etc. for commercial or R&D products
  • Coordinate and execute the manufacturing of projects associated with alternate sources of raw materials, new product development, product and process optimization batches etc. Upon the completion of product processing, ensure robustness of the process and formulation which will support any NDA/ANDA filing
  • Review, as necessary, all pertinent documentation, cleaning procedures, batch history and technical transfer reports prior to validation and/or scale-up activities
  • Attend team meetings as Process Operations representative as required
  • Work with the R&D Formulator on the process development of projects
  • Must participate and successfully complete all required training
  • Perform other duties as assigned

Qualifications

  • Bachelor’s Degree in Pharmacy or relevant science/engineering discipline. Master’s Degree in Pharmaceutical Engineering a plus
  • Technical understanding and hands on experience with pharmaceutical unit operations
  • Proficiency with Quality by Design (QbD) concepts, statistical process control (SPC) and complex data analysis
  • Hands on experience using statistical data analysis tools
  • Strong computer skills, Microsoft Word, Excel, PowerPoint
  • Exceptional planning and coordination skills and an ability to adapt to changes in priorities and project schedules
  • Attention to detail in documentation work and reports
  • Strong written communication skills, creativity and enthusiasm
  • Ability to work well in a team setting and work on multiple projects
  • Clearly present data in team meetings
  • In depth knowledge of cGMP requirements and current industry practices
  • Flexibility to work in different shifts to achieve results. Primary shift is first shift
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents
  • Ability to effectively present information
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of trigonometry
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Apply Now