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. **Position: CSV Engineer** We are currently expanding our team and are looking for a **CSV Engineer**to support...

Roles & ResponsibilitiesResponsibilities:Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and...

**About the Role**: We are hiring a CSV Engineer to support pharmaceutical manufacturing projects in Singapore. The role focuses on validating GxP computerised systems to ensure compliance with relevant regulatory and data integrity standards across the project lifecycle. **Key Responsibilities**: - Author and review validation documentation (URS, FS, RTM,...

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...

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**: - Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. - Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems,...

As a Consultant, you will be working for our client in the respect of the applicable regulations and quality procedures and could be required to: Main Responsabilities: - Be responsible for preparing and executing test documentation for computerized systems. You should have excellent understanding of 21 CFR Part 11, 21 CFR Part 820, ISO 13485, and GAMP 5...

Roles & Responsibilities Responsibilities: Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data...

**Responsibilities**: - Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. - Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems,...