Validation Engineer

Vue: 187

Jour de mise à jour: 14-04-2024

Localisation: Ha Noi Ho Chi Minh

Catégorie: Assurance Qualité / Contrôle Qualité Pharmaceutique / Chimique / Biotechnologie

Niveau: Nhân viên

Salaire: Cạnh tranh

Éducation: Đại học

Expérience: 1 - 2 Năm

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Description de l’emploi

Work as project manager and perform validations related to sterility assurance of sterile medical devices from vendors in Asia, including but not limited to
- ETO sterilization validation
- Steam sterilization validation
- Packaging validation
Supervise and train vendors for ISO standards and Medline requirements
Perform audits and vigilance audits for sterile products related quality system and process; follow up CAPA/ SCAR and ensure appropriate evidences in a timely manner
Perform root cause investigation, troubleshooting and problems solving when non‐ expected situation happens.
Perform new products adoption into validated sterilization cycle including but not limited to bioburden, residual evaluation, packaging evaluation, etc.
Manage conflicts, interact with vendors and stakeholders, and communicate with internal team and cross‐functional teams.
Intensive travels to vendors to ensure meeting quality requirements.
Other work assigned by supervisor.

Education

Bachelor’s degree or above with science or engineering background. Biological and chemical background is preferred.

Relevant Work Experience

1‐2 years’ work experience in manufacturing. Experience in medical device is an advantage.
Fluent at both verbal and written English.
Microsoft Word and Excel experience at an intermediate level
Willing to travel with rate 50%
Good teamwork spirit, Good problem solving skills
Familiar with requirements and standards related to ISO11135, ISO11607 is preferred
Project management skill is a plus

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