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Validation Engineer

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Omrix Bio pharmaceuticals is seeking a Validation Engineer with focus on Cleaning validation

The Validation Engineer shall perform validation activities for base business and projects and independently manage the validation activities. This shall include authoring and reviewing qualification protocols and reports to ensure compliance with procedures and regulations, as well as overseeing execution of validation activities.

In addition, manages investigations for validation activities.

 

Duties and Responsibilities:

Generates, revises and executes documentation for validation studies ensuring compliance with internal procedures, standards and regulatory guidance documents.

Generating Cleaning validation plans, protocols and reports, executing CV sampling on the production floor for various process tanks and equipment.

Leading cleaning validation activities where needed.

Performing DQs, Impact Assessments, Criticality Assessments.

Generating and executing validation protocols Writing IQ, OQ and PQ protocols

Executing validations per protocols, Writing IQ, OQ and PQ Reports. Performing and summarizing various annual testing

Manages documentation for new and current validation activities and/or qualification procedures.

Ability to execute validations of a specific category, and to apply validation fundamentals and philosophy across a range processes and systems.

Partners cross-functionally to understand user needs and expectations of validation deliverables.

Initiates and performs investigations to close out validation discrepancies / exceptional conditions. Ensures appropriate resolution, documented justification and evaluates problems and issues.

Performs root cause investigations and appropriate statistical data analysis to ensure systems/ equipment and processes are in a state of control.

Participates in regulatory audits as technical expert for validation packages.

 

Education and/or Experience:

At a minimum, a BA/BSc degree or equivalent in Science or Engineering is required, or a technical diploma with practical engineering experience.

Minimum of 5 years’ experience in the pharma industry

Knowledge and experience in the validation field within the pharma industry.

Knowledge and experience in cleaning validation within the pharma industry.

Excellent personal skills, strong leadership and teaming, successfully collaborating in cross-functional environment.

אומריקס הינה חברה ביו-טכנולוגית המייצרת ומפתחת מוצרים מצילי חיים ב- 2 תחומים: ביוכירורגיה וחיסונים פאסיביים. החברה נוסדה ב 1995 ומתמחה בפיתוח וייצור של מוצרים ביוטכנולוגיים מתקדמים מפלסמה אנושית. אומריקס מועסקים מעל 500 עובדים בישראל, בשלושה אתרים מרכזיים: תל השומר, הר החוצבים ירושלים ונס ציונה.

הגעת לתפריט הנגישות, לחץ ENTER על מנת לדלג על התפריט.