Engineer II, Process
Meso Scale Diagnostics
Rockville, MD

About $61,000 - $84,000 a year

EducationSkills
POSITION SUMMARY

Responsible for developing, characterizing and validating manufacturing processes to produce biochemical assay plates and related consumables.

DUTIES AND RESPONSIBILITIES

  • Enhance existing manufacturing processes and implement new manufacturing processes in order to
o improve product quality
o reduce lot-to-lot variability
o expand the product portfolio
o increase manufacturing capacity
  • Design and conduct process experiments on manufacturing and pilot scale equipment to determine the impact of process variables on product properties
  • Work with suppliers to improve product quality and lot-to-lot reproducibility of purchased raw materials
  • Work with QC, Customer Service, R&D, QA and other groups to improve product performance
  • Support the corporate validation effort as required for ISO certification and FDA approval
  • Document and present experimental results in accordance with company procedures
  • Specific duties may vary depending upon departmental requirements
EXPERIENCE AND QUALIFICATIONS

  • Master’s degree in chemical/biochemical engineering or a related field
  • Minimum of 3 years of relevant experience
o PhD degree may be substituted for years of experience
  • Experience in quality standards such as GMP, ISO 9001 and ISO 13485 is preferred
KNOWLEDGE, SKILLS AND ABILITIES

  • Strong knowledge of process development techniques (such as process optimization, process control, design of experiments) and statistical analysis
  • Superior analytical and problem solving skills
  • Desire to work in a technically challenging, team-orientated environment
  • Demonstrated ability to move project tasks forward in an orderly and structured fashion
  • Excellent oral, written communication and interpersonal skills
  • Proficiency with the MS Office Suite and Minitab
  • Demonstrated knowledge of coating techniques, fluid dispensing, drying/desiccation techniques and protein stabilization
  • Demonstrated ability to multi-task and work productively in a demanding research environment with changing priorities
PHYSICAL DEMANDS

This position requires the ability to communicate and exchange information, utilize manufacturing and laboratory equipment, and move about the office and manufacturing floor.

WORK ENVIRONMENT

This position will spend time in a Clean Room environment.