Senior Validation Engineer
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day more than 4000 of us are challenging whats possible and making headway to help improve outcomes.
Ensure that all validation activities are in compliance with China GMP cGMP cGLP QSR (including Design Controls) ISO or other applicable requirements.
确保验证活动符合China GMPcGMPcGLPQSR包括设计控制ISO或其它适用的要求
Determine scope and strategy for validation. Drafting Validation Master Plan for site and project.
确定验证的范围和策略 编写工厂/项目验证主计划
Generation and execution of qualification/validation protocolsIQ/OQ/PQ including but not limited to equipment qualification process validation etc.
编写和执行确认/验证方案IQ/OQ/PQ包括但不限于设备验证工艺验证等
Be responsible for facilities/utilities validation such as clean HVAC system compressed air system purified water system water for injection system etc.
负责公用设施验证例如洁净空调系统压缩空气系统纯化水系统注射水系统等
Serve as site validation representative on cross functional teams for transfer NPI and other projects as necessary including supervision of contract validation resources.
作为跨职能团队的验证代表负责转移新产品导入和其他必要的项目包括监督合同验证资源
Generate and manage validation procedures such as Process Validation Procedure CSV Procedure etc.
编写和管理验证程序文件例如过程验证流程计算机软件验证流程
Support China GMP FDA inspections ISO certifications surveillance audits and customer audits
支持中国GMPFDA检查ISO认证监督审核和客户审核
Other work assigned by supervisor.
主管安排的其它工作
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency and it must be executed and authorized by the Vice President Talent Acquisition. Where agency agreements are in place introductions (the initial sharing of a candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.
Required Experience:
Senior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative te ... View more
