Lead Computer System Validation Emea

Vor 6 Tagen

Zug, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson is currently recruiting a Lead Computer System Validation EMEA (New Consumer Health Company). This position is located in Zug, Switzerland or France..

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science bringing innovative ideas, products, and services to advance the health and well-being of people.

With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

The Lead CSV EMEA is responsible for building and executing of quality into enterprise-wide systems, tools, services, and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire)
- The individual ensures company quality standards and regulatory requirements are met for the systems under the scope of responsibility
- The role is responsible for planning, executing, coordinating, and maintaining the validation activities for the systems within their scope; including approval of SDLC validation documentation, release system implementation and/or changes for production use, providing computerized systems validation guidance and support to support team members in the execution of system base business activities, enhancements, and small projects.
- The individual reviews and approves SOP and WIs related to the systems within their scope and assists with incident management/CAPA and NCs for systems supported
- This position will support internal audits, Health Authority regulatory inspections, and system periodic reviews

**Qualifications** Position Requirements**:

- A Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another related field required; relevant experience may be substituted when appropriate; additional certifications a plus
- A minimum of 4-6 years of progressive industry experience, with direct experience in Computerized System Validation (CSV) in GxP environments
- Experience authoring or approving validation deliverables, Non-conformities, Change Requests, SOPs, Validation Plans and Reports
- Knowledge of Data Integrity, cGMP regulations related to CSV
- Experience providing CSV support in at least one of the following areas: ERP, Laboratory or Manufacturing systems, medical device software, infrastructure qualification, hosted platforms, emerging technologies (e.g. AI, ML, RPA) or externally facing digital assets (e.g. mobile apps, Websites that include both static and dynamic processing)

**Preferred Competencies**:

- Multi-lingual (German, Dutch or French)
- Working knowledge of Quality Management Systems, PMO, SDLC, Testing, GAMP 5, and ITIL frameworks
- Ability to perform work with a high degree of independence in terms of self-management of a variety of tasks
- Solutions oriented, striving for new ways to accomplish goals and pragmatic advising in meeting compliance requirements
- Works effectively in a virtual team environment; comfortable collaborating and communicating with various cross-functional groups
- 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**
France-Haute-de-Seine-Issy Les Moulineaux
- **Other Locations**
Switzerland-Zug-Zug

**Organization**
Ethicon S.A.S. (7840)

**Job Function**
Quality

**Requisition ID**
2206072604W

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