gmp Quality Validation Engineer

4 weeks ago


Hopkins, United States Medvacon Life Sciences Full time
Job DescriptionJob Descriptioncgmp Quality Validation Engineer
NO AGENCIES
W2 only
On-site position
6+ months

Leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations.

SCOPE:

Owner
of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.

RESPONSIBILITIES:
  • validation plans, protocols and reports for assembly and packaging processes
  • validation standard operating procedures in compliance with regulatory requirements
  • validation protocol and report templates
  • test method validation (TMV) protocols and reports for automated and manual inspection methods. 
  • quality engineering support for semi-manual and automated equipment development equipment
  • URS, FAT/SAT against quality requirements.
  • support design transfer of internal manufacturing processes.
  • statistical analysis of validation and production data
  • manufacturing process development & qualification for product changes
  • continuous improvements
  • leads CAPA/NCR/SCAR investigations and reports.
  • internal & external audit
  • complaint investigations

REQUIREMENTS 

Bachelor's degree in engineering (Mechanical or Biomedical) or related Science 
5-7 years relevant experience within medical device industry or related function
ASQ certification a plus

 

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