Lead Validation Engineer
OH-70344345 Alkermes seeks Lead Validation Engineer in Wilmington OH.
Serve as subject matter expert for Process and Cleaning Validation for pharmaceutical products, including lead/structure scientific assessment; determine levels of importance/risk for elements under review; extract definition of science underpinning element under review; present valida- tion effort to reviewers/auditors; apply science/areas of technical knowl- edge to development & presentation of validation approach; contribute to validation policies/guidance; apply best industry practices; ensure validation systems meet industry demands; present validation approach to potential clients; participate in professional/ industry groups.
Reqs:
Bach in Chemistry, Biology, Chemical Engineering, Pharmacy or equiv and 6 yrs exp in Process and Cleaning Validation in pharmaceutical field (in alternative, will accept Master s & 4 yrs exp), including:
4 yrs in commercial pharmaceutical cGMP MoH regulated industry, 2 yrs working on cleaning validation to define validated cleaning campaign lengths in- cluding both Clean and Dirty Hold Times, 2 yrs in process and cleaning of microsphere equipment, and 1 yr using Valgenesis, Trackwise, and Veeva quality systems (exp can be gained concurrently); knowledge of aseptic sampling for Bioburden, TOC, and Endotoxin sample collection, Rinse and Negative Control sample selection, statistical process evaluation utilizing JMP software, applicable regulatory requirements for Process/ Cleaning Validation.
By resume to email protected .
jobmatchohio.
com.
Keywords:
Quality Control / Quality Assurance Engineer, Location:
Wilmington, OH - 45177 Recommended Skills Biology Chemical Engineering Regulatory Requirements Sample Collection Industry Practices Auditing Estimated Salary: $20 to $28 per hour based on qualifications.
Serve as subject matter expert for Process and Cleaning Validation for pharmaceutical products, including lead/structure scientific assessment; determine levels of importance/risk for elements under review; extract definition of science underpinning element under review; present valida- tion effort to reviewers/auditors; apply science/areas of technical knowl- edge to development & presentation of validation approach; contribute to validation policies/guidance; apply best industry practices; ensure validation systems meet industry demands; present validation approach to potential clients; participate in professional/ industry groups.
Reqs:
Bach in Chemistry, Biology, Chemical Engineering, Pharmacy or equiv and 6 yrs exp in Process and Cleaning Validation in pharmaceutical field (in alternative, will accept Master s & 4 yrs exp), including:
4 yrs in commercial pharmaceutical cGMP MoH regulated industry, 2 yrs working on cleaning validation to define validated cleaning campaign lengths in- cluding both Clean and Dirty Hold Times, 2 yrs in process and cleaning of microsphere equipment, and 1 yr using Valgenesis, Trackwise, and Veeva quality systems (exp can be gained concurrently); knowledge of aseptic sampling for Bioburden, TOC, and Endotoxin sample collection, Rinse and Negative Control sample selection, statistical process evaluation utilizing JMP software, applicable regulatory requirements for Process/ Cleaning Validation.
By resume to email protected .
jobmatchohio.
com.
Keywords:
Quality Control / Quality Assurance Engineer, Location:
Wilmington, OH - 45177 Recommended Skills Biology Chemical Engineering Regulatory Requirements Sample Collection Industry Practices Auditing Estimated Salary: $20 to $28 per hour based on qualifications.
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