Validation Engineer - FWN
Implements process validation, SIP, sterilization, depyrogenation and re-validation activities to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and Novartis Quality Modules.
1st shift, as exempt of a support group. Will require weekend and off hours
Validation Activities: Ensure that assigned validation activities are performed timely and in line with the current Novartis requirements and cGMP, handling any deviations associated with these activities. Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Re-qualifications, Annual Monitoring Batches). Perform process qualification for new equipment and new technologies. Participate in transfers and launches. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation. Perform risk assessments for Validation. Participate in improvement and remediation of products. Provide Validation oversight review and approval of Production documentation, e.g. Master Batch Records (MBRs) and Standard Operating Procedures (SOPs).
Training: Own the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions. Audit Support: Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.
Meet established validation and re validation milestones according to approved validation plans that do not adversely impact production schedule nor audit readiness. Success rate during audits/inspections. Transfers/launches and projects implemented on schedule and on target. Validation Key Performance Indicators (KPIs). Technical reports executed on time and with the right expectations. Technical/scientific development as a member of the site Subject Matter Experts (SME) team. Training curriculum up-to-date. All contractors (if assigned) trained according to the training curriculum. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements 1st shift, as exempt of a support group. Will require weekend and off hours
Bachelor's degree or 8 equivalent years of directly related experience
Fluent in English
- 0-4 years experience in manufacturing/manufacturing science and technology/technical development/Quality.
2 years manufacturing experience.
- Basic understanding of manufacturing processes and related process equipment.
- Working knowledge of applied statistics, quality systems.
- Writing technical documents.
- Fundamental understanding of standard pharmaceutical analytical testing.
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