- Use principles based on validation science and risk management tools (e.g. FMEA) to lead in the development and maintenance of Validation Master Plan(s) for process, systems, cleaning and packaging.
- Establish and maintain an overview of the state of validation for assigned projects and product platforms, and assist in establishing the project prioritization across JCM Site.
- Lead in the translation of critical process parameters and process control strategy into a focused risk-based approach for process validation.
- Develop routine re-validation protocols, deviations and reports, including the review of associated Device Master Record (DMRs) and change controls, and provide field execution support.
- Partner with Engineering, QA, IT and Production to define roles and responsibilities for qualification and validation deliverables.
- Support engineering activities to ensure appropriate validation deliverables are clearly defined resulting from technical changes.
- Serve as the Lead validation representative for all internal or external audits to ensure site readiness in support of successful inspections e.g. no critical observations related to validation activities.
Position Location : Johns Creek, GA
Key Performance Indicators:
- Established validation and revalidation milestones met according to approved validation plans.
- No critical/ major observations during audits/ inspections.
- Transfers/ launches implemented on schedule and on target without validation related issues.
Minimum requirements Bachelor's Degree or equivalent years of directly related experience. The ability to fluently read, write, understand and communicate in English. 5 Years of Relevant Experience.
Minimum Required: BSc. in Chemistry, Pharmacy, Engineering, or equivalent.
Preferred Level: MSc. in the above or equivalent.
- Hands-on experience in Manufacturing/ Manufacturing Science and Technology/ Technical development and Quality.
- Thorough understanding of manufacturing processes and related process equipment.
- Experience writing technical reports
- Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
- 10 years validation experience in Pharmaceutical and/or Medical Device industry.
- 8 years of experience in Manufacturing/ Manufacturing Science and Technology/ Technical development and Quality.
- Strong working knowledge of engineering principles, applied statistics, quality systems and regulatory requirements across multiple health authorities.
Fluent in English (ability to read, write, understand, and communicate).
Alcon Research, LLC. Profile:
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or 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. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to firstname.lastname@example.org and let us know the nature of your request and your contact information.
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.