Validation Engineer
1 month ago
Job Summary:
The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes lead and/or execute validation activities, including equipment, process, test method and software validation, to ensure that products are manufactured consistently and reliably in accordance with Good Manufacturing Practices (GMP) and other relevant standards.
Essential Duties and Responsibilities:Include the following. Other duties may be assigned.
Validation Planning and Execution:
- Discuss and develop Master Validation Plan with the engineering / NPI team during the NPI process.
- Develop, implement, and maintain validation protocols and procedures for equipment, processes, and systems in accordance with regulatory requirements and industry best practices.
- Lead the execution of validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.Establish and execute the Test Method Validation.
- Exercise authority to make technical decisions related to validation activities and methodologies.
- Perform risk assessments to identify critical areas and establish validation strategies.
- Ensure the re-validation and periodic review is conducted in a timely manner.
Documentation and Reporting:
- Prepare and review detailed validation documentation, including validation plans, protocols, reports, and change control documents.
- Maintain and update the Master Validation Plan as and when required.
- Authorize and approve validation documents and reports prepared by other team members.
- Maintain accurate and complete records of validation activities and results.
Compliance and Quality Assurance:
- Ensure validation activities comply with FDA regulations, ISO standards (e.g., ISO 13485), and other relevant guidelines.
- Support internal and external audits and regulatory inspections.
- Investigate and resolve validation-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
Cross-functional Collaboration:
- Collaborate with engineering, manufacturing, and quality assurance teams to ensure seamless integration of validated systems and processes.
- Provide validation expertise and exercise authority in decision-making during the development and implementation of new processes, equipment, and technologies.
- Oversee and support the training of personnel on validation procedures and best practices.
Continuous Improvement:
- Identify opportunities for process improvements and efficiency gains within the validation scope.
- Stay current with industry trends, technological advancements, and regulatory changes related to validation and medical device manufacturing.
- Implement improvements and best practices within the validation framework, with the authority to drive change.
Tell employers what skills you have
Microsoft Office
FDA
Risk Assessment
Quality Assurance
Manufacturing Processes
ISO
GMP
Investigation
Protocol
Python
Medical Devices
Audits
Change Control
Regulatory Requirements
Manufacturing
Commissioning
-
Engineer, Validation
5 days ago
Singapore This is an IT support group Full timeToday, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....
-
Validation Engineer
2 days ago
Singapore PSC BIOTECH PTE. LTD. Full timeRoles & ResponsibilitiesJob Description & RequirementsJob Description: Completing work assignments as specified by the Validation Project Manager Providing timely updates to the Validation Project Manager Adhering to the proper site safety practices; wearing adequate safety equipment when required Completing timesheets and expense reports in a timely...
-
Validation Engineer
2 weeks ago
Singapore PSC BIOTECH PTE. LTD. Full timeRoles & ResponsibilitiesJob Description & RequirementsJob Description: Completing work assignments as specified by the Validation Project Manager Providing timely updates to the Validation Project Manager Adhering to the proper site safety practices; wearing adequate safety equipment when required Completing timesheets and expense reports in a timely...
-
Senior Validation/Validation Engineer
1 month ago
Singapore ESCO ASTER PTE. LTD. Full timeRoles & ResponsibilitiesThe OpportunityEsco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in...
-
Validation Engineer
2 days ago
Singapore LIONSBOT INTERNATIONAL PTE. LTD. Full timeRoles & ResponsibilitiesAs a Validation Engineer, you play a pivotal role in our organization by ensuring that each product release surpasses quality expectations. Your responsibilities encompass understanding potential system failures, designing validation scenarios, and driving continuous improvement initiatives. Acting as a gatekeeper in a dynamic product...
-
Validation Engineer
2 weeks ago
Singapore LIONSBOT INTERNATIONAL PTE. LTD. Full timeRoles & ResponsibilitiesAs a Validation Engineer, you play a pivotal role in our organization by ensuring that each product release surpasses quality expectations. Your responsibilities encompass understanding potential system failures, designing validation scenarios, and driving continuous improvement initiatives. Acting as a gatekeeper in a dynamic product...
-
Validation Engineer
2 days ago
Singapore ANTER CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities: Develop and execute Commissioning, Qualification, and Validation (CQV) protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facilities, equipment, and systems. Collaborate with project teams to ensure compliance with regulatory standards (e.g., FDA, EMA, GMP). Perform risk assessments, gap analysis, and prepare...
-
Validation Engineer
2 weeks ago
Singapore ANTER CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities: Develop and execute Commissioning, Qualification, and Validation (CQV) protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facilities, equipment, and systems. Collaborate with project teams to ensure compliance with regulatory standards (e.g., FDA, EMA, GMP). Perform risk assessments, gap analysis, and prepare...
-
Engineer 2, Validation
3 days ago
Singapore Lonza Group Ltd. Full timeToday, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....
-
Validation Engineer
2 days ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...
-
Validation Engineer
3 months ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...
-
Process Validation Engineer
2 months ago
Singapore Takeda Full timeAbout the Role:The Process Validation Engineer will be responsible for providing process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. This includes overseeing process validation activities, developing and authoring process validation strategies, and ensuring compliance with cGMP...
-
Validation Engineer
2 days ago
Singapore SILICON LABORATORIES INTERNATIONAL PTE. LTD. Full timeRoles & ResponsibilitiesMeet the TeamSilicon Labs is seeking experienced validation engineer for a new IoT MCU Validation team. The ideal candidate is an enthusiastic detail-oriented system level engineer with a solid understanding of low power MCU architectures in terms of both digital and analog aspects. The position also requires software proficiency at...
-
Validation Engineer
2 weeks ago
Singapore SILICON LABORATORIES INTERNATIONAL PTE. LTD. Full timeRoles & ResponsibilitiesMeet the TeamSilicon Labs is seeking experienced validation engineer for a new IoT MCU Validation team. The ideal candidate is an enthusiastic detail-oriented system level engineer with a solid understanding of low power MCU architectures in terms of both digital and analog aspects. The position also requires software proficiency at...
-
Data Validation Engineer
2 weeks ago
Singapore AMARIS CONSULTING PTE. LTD. Full timeOverviewAmaris Consulting, a global technology consulting firm, offers expertise in various business lines, including Information System & Digital, Telecom, Life Sciences, and Engineering.Estimated Salary Range: $80,000 - $110,000 per annumJob DescriptionThe ideal candidate will possess strong coding skills and experience in configuring DeltaV systems....
-
Junior Validation Engineer
1 month ago
Singapore ANTER CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesWe are seeking a Junior Validation Engineer with 0-3 years of experience to support validation activities, ensuring compliance with regulatory and quality standards, especially GMP. The role involves collaboration with cross-functional teams to meet project goals.Key Responsibilities: Develop, review, and execute validation protocols...
-
Engineer 3, Validation
2 weeks ago
Singapore LONZA BIOLOGICS TUAS PTE. LTD. Full timeRoles & ResponsibilitiesToday, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our...
-
Validation Engineer
2 weeks ago
Singapore AMARIS CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesAmaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7500 people spread across 5 continents and more than...
-
Validation Engineer
19 hours ago
Singapore RIGHT RECRUIT PTE. LTD. Full timeRoles & ResponsibilitiesProcess Engineer/ Validation Engineer/ Equipment Engineer Working Hours: 8.15 - 5.45pm Mon -Fri Permanent Position / MNC Near Woodlands InterchangeOur client is a global advanced precision engineering & manufacturing solutions provider.Responsibilities: Prepare and execute process validation protocols (MVP/IOPQ) and reports for...
-
Validation Engineer
2 weeks ago
Singapore RD TRUSTED PARTNERS PRIVATE LIMITED Full timeRoles & ResponsibilitiesMonday to Friday, 8.30am to 6pmLocation: Tai SengOvertime allowance of $150 will be provided for working more than 8hoursResponsibilites1. Assist Quality and Validation Manager Asia to complete the tasks in time with good quality.2. Responsible for successful execution the Validation functions for customer project, as required –...