Sr. Specialist Qualification Engineer

hace 3 semanas

Xico, México Novartis A tiempo completo

**Summary**:- Contribute to challenge and improve local/simple business processes, products, services, and software through data analysis.-Engage with business representatives and support the appropriate DDIT teams and Functions to develop business requirements and deliver data driven recommendations to improve efficiency and add value.**About the Role**:**Major accountabilities**:- Participate in projects and operational changes to ensure that the creation of the qualification documentation is in compliance with Novartis standards and procedures- Create / Update the CSV deliverables for OT systems as per Novartis procedures- Advise and direct the site teams on industry best practices for the development of CSV protocols (including risk assessments, user requirements, functional specifications, and test qualifications)- Engage with the In-house service of qualification engineers / technical writers, to ensure consistency of documentation and compliance- Provide test management for the execution of qualification activities- Provide expertise and best practice on the use of the electronic validation and lifecycle management tool for commissioning / qualification activities- Participate in CSV related investigations and issue resolution, ensuring effective and timely remediation- Collaborate with Quality Assurance and e-Compliance teams to ensure that CSV activities are in compliance with Novartis procedures.- Act as a data quality checker of the Master Equipment Inventory of all sites**Key performance indicators**:- Feedback on dedicated phases for Project execution (quality, time) -Degree of customization vs configuration of COTS solutions.- Process efficiency (specific scope) -Steady/Uninterrupted process flow (specific scope) -Completeness and accuracy of Business Process Model (BPM) -local or non-complex processes -Business process documentation up to date (specific scope)**Minimum Requirements**:**Work Experience**:- Bachelor's degree in Computer Science, Engineering, or a related field.Master's degree preferred.- Minimum of 10 years of experience in computer system validation, with a focus on process automation systems.- In-depth knowledge of regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11) and industry best practices related to CSV.- Excellent problem-solving and analytical skills, with the ability to identify and resolve complex CSV issues.- Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders at all levels of the organization.- Detail-oriented mindset, with a focus on accuracy and compliance.- Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.- Certifications in CSV or related fields (e.g., GAMP 5, RAPS) are a plus.DivisionOperationsBusiness UnitCTSLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Job TypeFull timeEmployment TypeRegularShift WorkNo

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