Senior Validation Engineer
1 month ago
EPM are seeking a Contract Validation Engineer for one of our biopharmaceutical partners that specializes in key aspects of new drug development. This role with be Hybrid; Minnetonka, Minnesota
Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.This position 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. This position is the owner of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.
- Oversee validation and quality engineering for internally manufactured products
- Lead CAPA/NCR/SCAR investigations and reports
- Manage validation standard operating procedures in compliance with regulatory requirements
- Develop validation plans, protocols, and reports for assembly and packaging processes
- Design for Six Sigma and Critical to Quality training and experience a plus
- Support internal and external audits
Experience:
- 5-7 years of relevant experience within the medical device industry or related function
- Lead auditor certification preferred
- Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
Contract details:
- 6 months
- 40 hours
- W2 contract
- Anticipated Start: ASAP
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Senior Validation Engineer
2 months ago
Minneapolis, United States EPM Scientific Full timeEPM are seeking a Contract Validation Engineer for one of our biopharmaceutical partners that specializes in key aspects of new drug development. This role with be Hybrid; Minnetonka, Minnesota This position leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance...
-
Senior Validation Engineer
2 months ago
Minneapolis, United States EPM Scientific Full timeEPM are seeking a Contract Validation Engineer for one of our biopharmaceutical partners that specializes in key aspects of new drug development. This role with be Hybrid; Minnetonka, Minnesota This position leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance...
-
Senior Validation Engineer
2 months ago
Minneapolis, United States EPM Scientific Full timeEPM are seeking a Contract Validation Engineer for one of our biopharmaceutical partners that specializes in key aspects of new drug development. This role with be Hybrid; Minnetonka, Minnesota This position leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance...
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