Job Summary
IT Compliance Engineer - The IT Compliance Engineer ensures that IT infrastructure applications and data systems in a life science manufacturing environment meet GxP 21 CFR Part 11 EU Annex 11 and data integrity requirements. The role supports qualification validation and lifecycle control of systems manages audit readiness and partners with IT QA and Operations to maintain a secure compliant and inspection-ready state.
Responsibilities
- Perform infrastructure qualification (servers networks virtualization cloud) and support CSV activities per GAMP 5 for GxP applications
- Ensure IT systems comply with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) principles
- Develop review and maintain IT SOPs policies and validation documentation covering backup security access management and disaster recovery
- Manage change control deviations CAPAs and impact assessments for IT systems to maintain a validated state
- Conduct periodic reviews access reviews audit trail reviews and system risk assessments
- Support internal audits customer audits and regulatory inspections including preparing evidence and responding to findings
- Evaluate and qualify vendors cloud providers and service partners for GxP suitability and quality agreements
- Partner with Cybersecurity to align IT controls with compliance requirements (e.g. user access patching vulnerability management OT/IT segmentation)
- Monitor compliance metrics identify gaps and drive remediation and continuous improvement initiatives
- Provide compliance guidance and training to IT teams system owners and project teams on GxP and data integrity expectations
关于高知特 (Cognizant)
高知特(Cognizant)（纳斯达克代码：CTSH）作为一家AI Builder和相关技术服务提供商，致力于通过打造全栈AI解决方案，帮助企业将人工智能投资转化为实际价值。公司凭借深厚的行业经验、流程优化和工程技术专长，将企业独特的业务场景融入科技系统，赋能组织释放人才潜能，推动切实成果，并帮助全球企业在瞬息万变的环境中保持领先。如需了解更多详情，敬请访问 cognizant.ai 或关注@cognizant。
补充雇佣信息
薪酬信息截至本职位发布之日为准。Cognizant 保留在适用法律允许的范围内随时修改该信息的权利。
申请人可能需要通过现场面试或视频会议的方式参加面试。此外，候选人在每次面试时可能需要出示其当前所在州或政府签发的有效身份证件。
Cognizant 是一家提供平等就业机会的雇主。在招聘过程中，您的申请和候选资格不会因种族、肤色、性别、宗教、信仰、性取向、性别认同、国籍、残疾、遗传信息、怀孕、退伍军人身份或任何其他受联邦、州或地方法律保护的特征而受到影响。
