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Senior Computer System Validation (Csv) Specialist

Senior Computer System Validation (Csv) Specialist
Empresa:

Johnson&Johnson


Detalles de la oferta

Johnson & Johnson Surgical Vision (JJSV), a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Computer System Validation (CSV) Specialist. This position will be located at Añasco, Puerto Rico.

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Senior Computer System Validation (CSV) Specialist will serve as primary Quality Assurance associate responsible for the overall oversight of the AMO Puerto Rico Manufacturing Systems Development Life Cycle (SDLC) and systems compliance to 21 CFR Part 11. The individual performing this role will have to create a strong network base with technical resources and engineers to develop or coordinate the implementation of activities to maintain the systems compliance to 21 CFR Part 11, systems version controls, and validated state. Overall responsibilities include the coaching, training and guidance on aspects of validations and qualifications for technical resources to ensure compliance with established procedures.

This role serves as the JJSV Añasco Computer System Validation (CSV) SME responsible for the implementation of policies and procedures required to meet company requirements. It contributes with the development, implementation and execution of quality systems procedures in support of CSV processes. Reviews and approves validation related documentation to ensure that validations and procedures are consistent with current regulatory requirements, current technology, company validation policies and procedures.

You will:
• Perform and/or coordinate all the activities related to the systems development life cycle (SDLC) of the AMO Puerto Rico Manufacturing computerized systems that support the business operation
• Conduct benchmarking to evaluate new and existing systems and recommends / implements enhancements that will increase compliance according to 21 CFR Part 11.
• Ensure effective quality strategies are created for the validation of computerized systems and writes CSV procedures, systems documentation, user and training manuals, validation protocols, and other required documentation by company policies and procedures.
• Develop, implement and update the Disaster Recovery Plan for critical systems under area of responsibility.
• Provide support to the validation and certification of computerized systems representing the validation function in computerized systems validation projects, with the objective to assure that departmental quality objectives are met.
• Participate in VRB to document, explain, review or analyze that a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard.
• Responsible for reviewing / approving CO’s requiring CSV approval as required.
• Champion compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive requirements) including providing support during internal and external audits.
• Ensure proper systems compliance with Corporate and Divisional systems policies and procedures. Ensure requirements for Manufacturing Execution Systems (MES), Electronic Device History Records (eDHR's) are aligned with users, quality & compliance and business requirements.
• Provide guidance and oversees contract employees for day to day assignments as required.

Qualifications
• A Bachelor’s or higher degree is required. Major in Computer Sciences, Computer Engineering is highly preferred.
• A minimum of four (4) years of related experience within the manufacturing regulated environment is required.
• At least four (4) years of knowledge and experience with all phases of computerized systems validation is required.
• Experience working in both an FDA and European regulatory environment is preferred.
• Solid understanding of FDA regulations applicable to information systems (21 CFR Part 11) is preferred.
• Knowledge of Quality regulations and standards affecting medical devices (i.e. Quality Systems, FDA regulations, and EN46000) is preferred.
• At least 3 years of experience in MES/QA systems development and integrations (SAP, BPCS, MES, etc.) is preferred.
• At least 6 years of knowledge and experience with all phases of SDLC is preferred.
• Practical knowledge of operating systems (Windows 2000, Windows 2003, Windows XP, Window 7 and Windows 10).
• Excellent written and verbal skills both in English and Spanish is required.
• Strong problem-solving skills.
• Position requires up to twenty percent (20%) of domestic and international travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Primary Location
United States-Puerto Rico-Anasco- Organization
AMO Puerto Rico Manufacturing, Inc. (Branch) (7239)
Job Function
Quality
Requisition ID
2105889848W


Fuente: Bebee2

Requisitos

Senior Computer System Validation (Csv) Specialist
Empresa:

Johnson&Johnson


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