Process Validation Engineer
2 days ago
Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on Process Equipment, CIP / SIP, Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations, Method validation (analytical chemistry, biochemistry, microbiological) & Enterprise system (LIMS, QMS).
- Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.
- Develop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practices.
- Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
- Investigate deviations, write investigation reports and create summary reports.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
**Requirements**:
- Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description.
- Minimum 3 years of experience in pharmaceutical industry
- Experiences in commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer.
- Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred
- Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
- Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system.
- Designing and conducting test methods validation (sterility test, disinfectant test, et
- Strong knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
Reg No. R1875181
Triton AI Pte Ltd
License no. 21C0661
**Benefits**:
- Permanent Role
- Up to $7,500 + 2 months VB
- Pharmaceutical Industry Experience is a MUST
- CIP, SIP experiences will be preferred
-
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...
-
Process Validation/characterization Engineer
5 days ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time**Responsibilities**: - Support process validation and characterization studies. - Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely manner or in accordance to project timelines. - Manage the execution of process validation and...
-
Process Validation/characterization Engineer
6 days ago
Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time**Responsibilities**: - Support process validation and characterization studies. - Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely manner or in accordance to project timelines. - Manage the execution of process validation and...
-
Process Validation Engineer
5 days ago
Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time**Responsibilities**: - Support process validation and characterization studies. - Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely manner or in accordance with project timelines. - Manage the execution of process validation...
-
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...
-
QA Validation Engineer
12 hours 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...
-
QA 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 clients....
-
Engineer Validation
5 days ago
Singapore Manufacturing & Operations Full timeJob Description The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes leading and/or executing validation activities, including equipment, process, test method, and software validation, to ensure that products are manufactured consistently...
-
Facitilites/utilities Validation Engineer/lead
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...
-
Validation Engineer
2 weeks ago
Singapore GDMC Full time**Validation Engineer / Validation Manager**: At Genetic Design and Magic Corporation (GDMC), our mission is to exponentially increase the availability of genetic medicines and change millions of patients' lives. We achieve this by partnering and supporting early-stage companies and investigators with innovative therapeutic modalities such as gene therapies...