Cellares
cell therapy manufacturing
SeniorValidationEngineer(I,II,III)
“Senior Validation Engineer (I, II, III) at Cellares. Skills: qualification and validation, GMP regulated environment, technical writing. Generate qualification and validation documents. Review validation protocols and reports”
Industry & Context.
solution oriented; Identify qualification/validation gaps; strategize on solutions; drive gap mitigation
What They're Looking For.
Must Have
Bachelor's degree in Engineering or a scientific related field, 8 years of experience working in a GMP regulated environment, 5 years qualification and validation hands on experience, Detailed knowledge of 21 CFR Part 210, 211, Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) requirements, Knowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11), Excellent technical writing skills, understanding of good documentation practice
Nice to Have
GAMP5 expected pharmaceutical standards
What You'll Do.
Generate qualification and validation documents
Review validation protocols and reports
Ensure maintenance of validated status
Support vendor qualification activities
Support change control program
Evaluate validation impact
Provide guidance on quality culture
Participate in continuous improvement
Provide status updates
Identify qualification/validation gaps
Strategize on solutions
Mentoring and training junior engineers
Foster collaborative approach
Participate in regulatory inspections
How You'll Work.
Team & Collaboration
Actively participate in continuous improvement activities with cross-functional teams; Foster collaborative approach to ensure harmonization of qualification/validation approach across all Cellares sites
Communication Scope
Excellent technical writing skills
Process & Methodology
project plans, project management
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