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...

Overview Join to apply for the CSV Engineer role at Antaes Asia . 4 days ago Be among the first 25 applicants. Responsibilities Contribute to Life Science projects for Antaes Asia clients. Work with cross-functional teams in providing Quality oversight in computerized system life cycle procedures and ensure compliance with GXP standards and company policies...

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...

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...

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...

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational...

1. Manage OT controls under automation team, including access control management with SailPoint, removable devices management, anti-virus patch management and OT asset management. 2. ⁠Support equipment/system qualifications, including Alarm Management System /PEMS/ QC equipment). 3. Experienced with GMP/GDP compliance requirements (FDA, EMA, GAMP 5, 21...

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

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 integrity, compliance to CSV Plan and...