CSV Engineer

**Position: CSV Engineer** At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists. We are currently expanding our team and are looking for a **CSV Engineer **to support...

**Senior CSV Engineer**: - Contract - Onsite - Singapore, Singapore - CQV - 7316 - SGD **Overview - We have an immediate requirement for 2 - **CSV Specialists **to join a highly skilled PM Group team based on a client site. **Responsibilities **Day to day activities include the following**_:_** - Commissioning and Qualification of hardware and associated...

We are seeking an experienced **CSV Engineer**to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with **21 CFR Part 11, Annex 11, GAMP 5**, and collaborating with cross-functional teams for successful project delivery. **Key...

We are seeking an experienced CSV Engineer to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with 21 CFR Part 11, Annex 11, GAMP 5 , and collaborating with cross-functional teams for successful project delivery.Key...

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services. We strongly uphold our core...

Job Description Contribute to Life Science projects for Antaes Asia clients Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan...

Responsibilities:Provides expertise in performing Computerized Systems Validation.Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations GxP, 21CFR11, etc.)Perform collaborative work with the Compliance Engineering team on...

**Responsibilities**: - Lead and execute Computerized Systems Validation (CSV) activities, including planning, testing, documentation, and reporting. - Collaborate closely with the Compliance Engineering team to support commissioning, qualification, and validation (CQV) activities. - Prepare, review, and approve qualification documentation (URS, DQ, FAT,...

This position is responsible for the validation of enterprise resource planning systems, automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus. In this role, the engineer has to work in accordance with the company’s policies and procedures to ensure validation is performed in accordance...

**Responsibilities**: - Will be required to prepare the quality review and ensure all approvals of qualification/validation documentation, and relevant data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria. - Provide overall quality oversight and validation for key functional areas...