Packaging Engineer - I

TekWissen LLC

Foster City, CA

JOB DETAILS
SALARY
$84–$90
SKILLS
Biomedical Engineering, Biotech and Pharmaceutical, Chemical Engineering, Communication Skills, Data Analysis, Diversity, Drug Development, HIV/AIDS (Acquired Immune Deficiency Syndrome), Hepatitis B, Hepatitis C, Industrial Engineering, Mechanical Engineering, Organizational Skills, Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Research & Development (R&D), Root Cause Analysis, Standard Operating Procedures (SOP), Technical Support, Technical Writing, Test Lab, Willing to Travel, Workforce Management, Writing Skills
LOCATION
Foster City, CA
POSTED
1 day ago
Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position: Packaging Engineer - I
Location: Foster City, CA 94404
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
  • This position resides within the Packaging Development team at Client, with a primary focus on the development, qualification, and lifecycle management of controlled temperature (cold chain) packaging systems (thermal protection systems) to ensure product quality and regulatory compliance across global distribution of our pharmaceuticals and biologics products.
Specific Job Requirements:
  • Author packaging protocols, reports, and technical documentation to support shipping qualification and regulatory filings
  • Design and execute qualification plans for thermal protection systems
  • Develop specifications for thermal protection systems components
  • Support deviation investigations and root cause assessments, as required
  • Download and analyze temperature monitoring data to support thermal qualification activities
  • Author and review SOPs related to shipping qualification activities ensuring alignment with other client quality systems and procedures
  • Potential for travel up to 10%.
Knowledge:
  • Strong technical skills and knowledge of package development and cold chain principals
  • Working knowledge of temperature-controlled shipping container qualification standards and regulations
  • Understanding of Good Distribution Practices
  • Strong communication, technical writing, and organizational skills
  • Experience collaborating with external suppliers and/or contract test laboratories is desirable
Specific Education and Experience:
  • B.S. degree in industrial engineering, mechanical engineering, biomedical engineering, chemical engineering, package engineering, or a related scientific field. Advanced degree(s) with commensurate industry experience considered.
  • Experience in the biotechnology or pharmaceutical industry preferred - 5+ years of hands-on experience
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/