Job Description

This is a laboratory-based position performing sample management, mechanical force testing, and other component/material characterization testing. Furthermore, this position may assist in data compilation, data presentations, report authoring, and department documentation support.

_ RESPONSIBILITIES:_

The responsibilities of this position include, but are not limited to:

• Work closely with other engineers in the evaluation, development, qualification and implementation of new components and container closure systems
• Support the formulation and process development groups to comply with regulatory requirements and guidance documents related to components and container closure systems
• Author and/or review engineering and development documentation such as component drawings, specifications, assembly drawings, tolerance stack analyses, risk analyses, etc.
• Execute designated test methods and protocols associated with component/device
• Provide general laboratory support, including ordering/replacement of reagents and consumables, general maintenance of equipment, continuous improvement activities, and participating in periodic lab inspections.
• This position will be responsible for preparing data summary presentations, providing data verification support, compiling data, and using lab-based systems for data collection such as electronic laboratory notebooks.
• Flexibility in support of additional biotherapeutics development activities including biophysical & biochemical characterization using techniques such as
  • HPLC
  • Capillary Gel electrophoresis (CGE),
  • Imaged Capillary Electrophoresis (iCE)
  • Spectroscopy techniques, light obscuration, microflow imaging

Qualifications

_ Minimum Qualifications:_

• Bachelor's Degree or higher in appropriate Science & Engineering disciplines, e.g. Chemistry, Biochemistry; Biomedical etc.
• A minimum of 2+ years relevant experience with the Pharmaceutical Parenteral Packaging Development
• Authorization to work in the United States indefinitely without restriction or sponsorship

_ Preferred Qualifications:_

• • Familiarity with eLN, Bluehill Software, ISO test methods, including ISO 11040 and ISO 80369, US/EP Pharmacopoeia and other standards, regulations and guidance associated with components, container closure systems and drug delivery devices.
• • Strong computer skills and experience with lab-based computer systems
• • Familiarity with standard biotherapeutics analytical techniques such as HPLC, CGE, iCE, Spectroscopy

Additional Information

Position is Full Time, Monday-Friday, 8am-5 pm. Candidates currently living within a commutable distance of Sain t Louis, MO are encouraged to apply

_ Excellent full-time benefits include:_

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.