Computer System Validation Engineer
4 days ago
Create, review or approve validation deliverables for GMP computerized systems including but not limited to:
- User Requirements Specifications
- Design Reviews
- Criticality assessments
- Validation protocols (IQ, OQ, PQ)
- Incident/deviation reports related to test protocol execution
- Provide validation guidance to cross-functional teams based on customers' Standard Operating Procedures (SOPs)Provide QA oversight and review during different phases of the automation & ITOT projects in the pharmaceutical manufacturing industry
**Requirements**:
- Degree in Engineering or Science, preferably in Chemical/Biochemical Engineering, Electrical Engineering or Computer Science/IT.
- Minimum 3 years of computer system validation or automation experience in Pharmaceutical manufacturing Industry
- Customer-focused and uphold high work quality standards
- Excellent communication skills - ability to communicate and collaborate effectively with various stakeholders
- Previous Emerson DeltaV, ITOT infrastructure, Rockwell/Siemens/Schneider BMS experience is preferred
- Experienced in developing and reviewing automation validation deliverables
- Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines
-
Computer System Validation
2 weeks ago
Singapore MATRIX PROCESS AUTOMATION PTE. LTD. Full time $40,000 - $120,000 per yearKey Responsibilities:Develop and execute test cases, test scripts, and validation protocols (IQ, OQ, PQ) in accordance with approved procedures.Prepare validation deliverables URS, Validation Plan, Traceability Matrix, Test Summary Reports, and Deviations.Support and coordinate validation testing activities under QA oversight.Ensure all documentation and...
-
Computer Systems Validation Engineer
2 weeks ago
Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full timePES 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...
-
Computer System Validation Specialist
2 weeks ago
Singapore PSC BIOTECH PTE. LTD. Full time**As a computer systems validation specialist you will work as part of a multidiscipline team, supporting the design, construction, commissioning and qualification of new and modified pharmaceutical and life science facilities, equipment and processes.** **Responsibilities**: - Primary focused on Emerson DeltaV, Siemens PLC, MES, LIMS and Data Historian...
-
System Validation Engineer
2 weeks ago
Singapore Micron Full time**Our vision is to transform how the world uses information to enrich life for all. **Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it...
-
Computer System Validation
1 day ago
Singapore Celestica Full timeReq ID: 119781 Remote Position: Hybrid Region: Asia Country: Singapore State/Province: Serangoon North **Summary**: **Detailed Description**: Performs tasks such as, but not limited to, the following: - Develops and executes validation plans, deliverables, and procedures that are consistent with the Celestica standards and the industry validation...
-
Computer System Validation Internship
2 days ago
Singapore Roche Full time $30,000 - $60,000 per yearAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...
-
Computer System Validation
4 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time**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 within our Life Sciences Division team and are...
-
Validation Engineer
6 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timeWe are currently expanding our team within our Life Sciences Division team and are looking for a **Validation Engineer**to support projects on site with a client. The following are key responsibilities: - Review and approval of computer system validation protocols and reports. - Preparation and management of CSV deliverables for laboratory instruments and...
-
Senior Staff Systems Validation Engineer
5 days ago
Singapore Maxlinear (Singapore) Pte. Ltd Full timeJob Responsibilities: Lead system validation activities for Ethernet PHY and switch products across multiple development phases Perform electrical verification and HSIO (USXGMII/XFI) characterization including signal integrity, jitter analysis, and eye diagram measurements Validate power consumption across various operating modes and system configurations...
-
Senior Staff Systems Validation Engineer
5 hours ago
Singapore MAXLINEAR ASIA SINGAPORE PRIVATE LIMITED Full timeJob Responsibilities:- Lead system validation activities for Ethernet PHY and switch products across multiple development phases Perform electrical verification and HSIO (USXGMII/XFI) characterization including signal integrity, jitter analysis, and eye diagram measurements Validate power consumption across various operating modes and system configurations...