Senior Validation Engineer
3 weeks 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
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
4 weeks 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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Senior Validation Engineer
4 weeks 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
4 weeks 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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