Johnson & Johnson Karrieren
QA IT CSV Engineer
Requisition ID: 1905715755W
The Johnson and Johnson Family of companies is comprised of more than 250 operating companies in 57 countries employing approximately 128,000 people. Johnson and Johnson is the world ‘s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related products for the consumer, pharmaceutical and medical devices & diagnostics markets. At least a billion people around the world are touched each day by what we do.
QA IT CSV Engineer – Ethicon Neuchatel, Switzerland (12 months)
The QA IT CSV Eng. shall oversee all computer system validation activities at Ethicon Neuchâtel site for business applications, QC laboratories and production manufacturing systems. This shall include oversight of the CSV requalification program as well as validation planning for all Business Application lifecycle management projects. Ensures sites comply with procedures and regulations, as well as coaching validation engineers on validation skills.
- Provides independent quality oversight, ensures compliance and technically appropriate cGMP oversight, and is executer of site validation activities/protocols/reports & SOPs as it relates for his business applications and computer system validations. Ensures the validated state is maintained throughout its lifecycle.
- Provides input of validation requirements and timelines as part of thorough validation planning for all activities at the sites. Partners cross-functionally to ensure validation planning is timely and appropriate for validation activities.
- Develops, implements and maintains validation policies, procedures, templates, forms and supports a culture of continuous improvement.
- Adapts compliance tools and methodologies to the needs of the project.
- Ensure validation approach to ensure continuous improvement consistent with established and evolving regulatory and company environment. Proactively assesses the impact of regulatory changes on the business and IT processes and advises management of the implications.
- Provides guidance and oversees complex investigations to close out validation discrepancies / exceptional conditions. Ensures appropriate resolution and documented justification.
- Assesses and manages compliance risks, escalating to management as necessary.
- Participates in regulatory audits as SME for CSV validation packages. Ensures validation activities are consistent with applicable regulatory requirements and appropriately conveyed to regulatory bodies via associated regulatory submissions or as required.
- Participates in audits to explain compliance tools and methodologies and identifies gaps in audit readiness.
- At a minimum, a bachelor’s degree is required in Engineering, Computer Science or equivalent in Science or Engineering.
- Minimum of 1 - 3 years’ experience in medical and/or pharmaceuticals products.
- Experience participating and successfully collaborating in cross-functional project team environments.
- Project management experience preferred.
- Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives required.
- Thorough knowledge of GMPs related to validations as well as FDA and EU regulatory requirements for medical device products.
- Strong collaboration, communication, presentation and influencing skills required.
- The ability to interact and gain the support of key stakeholders required.
- Business fluent in English and very good knowledge in French
- Excellent organizational and communication skills (written and verbal)
- Ability to prioritize and manage multiple projects consisting of varying degrees of complexity
- Ability to analyze complex problems and apply practical solutions
ETHICON Women's Health & Urology Sarl (8566)