Packaging Engineer (Medical Device)
Job Description
Company: Tranzeal Incorporated
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About the job
Role: Packaging Engineer (Medical Device) Location: South San Francisco, CA (Onsite)
3 years’ experience in pharmaceutical or medical device industry Experience with large modules and medical device packaging is required Bachelor’s degree in Packaging Engineering or Materials Science (preferred) Develop primary and secondary packaging solutions Work closely with local packaging sites Knowledge of TOPS, CAD/SolidWorks, MS Project, and Adobe Familiar with ASTM, UST packaging standards and FDA regulations Knowledge of packaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation Knowledge of packaging process equipment, related to steriles, and non-steriles, and combination products packaging activities (e- g
- vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serialization
Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities Knowledge of design control for combination products Working knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and Adobe Knowledge of industry best practices and technical writing skills such as GMP and GDP
Please share your updated resume at subhd@tranzeal- com
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