Equipment Validation Engineer
2 months ago
Responsibilities:
- Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas: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.
Professional Skills and Experience:
- Bachelor’s degree in technical discipline such as Engineering, Pharmaceutical Science or with experience relevant.
- Minimum 2 - 3 or more years of experience in several functions in pharmaceutical industry: 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.
- Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
- Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline.
- Preferred to have experience interacting with or creating material for management and regulatory agencies.
Interested candidates please apply online or send your latest CV to alex.fong@AlwaysHired.com.sg
AlwaysHired Pte Ltd
Reg No: R1549345
EA: 24C2293
Tell employers what skills you have
Biochemistry
Analytical Chemistry
Pharmaceutical Industry
Manufacturing Engineering
Risk Assessment
Technology Transfer
ISO
Investigation
Process Manufacturing
Equipment Maintenance
LIMS
Regulatory Requirements
Laboratory
Manufacturing
Commissioning
-
Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full timeJob Title: QC/Lab Equipment Validation Engineer- PharmaPES International, a leading provider of project management, construction management, commissioning, and qualification services, is seeking a highly skilled QC/Lab Equipment Validation Engineer to join our team.We are a global company with offices across Europe, Asia, and the US, serving multinational...
-
Validation Engineer
1 month ago
Singapore One Stop Management Services Private Limited Full timeValidation engineers manage, inspect, calibrate, test and modify the instrumentation, equipment, mechanics and procedures used in manufacturing. A critical aspect of their job is documenting this process so there is evidence that systems are operating safely and efficiently.Validation engineers can be found in a range of industries, including aerospace,...
-
Validation Engineer
1 month ago
Singapore One Stop Management Services Private Limited Full timeValidation engineers manage, inspect, calibrate, test and modify the instrumentation, equipment, mechanics and procedures used in manufacturing. A critical aspect of their job is documenting this process so there is evidence that systems are operating safely and efficiently. Validation engineers can be found in a range of industries, including aerospace,...
-
Validation Engineer
3 days ago
Singapore ONE STOP ENGINEERING PTE. LTD. Full timeRoles & ResponsibilitiesWe are currently looking for potential candidate to provide expertise in EFU Validation activities. Contract period will be 1 year and availability as soon as possible.Below are the requirements for Validation Engineer (Equipment/ Facilities/ Utilities):Major Responsibilities: Act as the Subject Matter Expert (SME) related to E/F/U...
-
Validation Engineer
3 days ago
Singapore ANTER CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesWe're currently on the lookout for Validation Engineers for the Pharmaceutical Industry.Candidates should possess the following skillset : Developing and executing validation protocols for new processes, equipment, and systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification...
-
Validation Engineer
3 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timeRoles & ResponsibilitiesPosition: Validation Engineer in SingaporeJob DescriptionWe are currently expanding our team and are looking for a CQV Engineer for our project on site with our client.You will be responsible for planning, writing, implementing and reviewing Validation protocols in place within highly regulated environments. Your expertise will lend a...
-
Validation Specialist
3 days ago
Singapore ANTER CONSULTING PTE. LTD. Full timeValidation EngineerAt ANTER CONSULTING PTE. LTD., we are seeking a skilled Validation Engineer to join our team. As a key member of our pharmaceutical industry team, you will be responsible for ensuring the quality and integrity of our processes and equipment.Key Responsibilities:Develop and execute validation protocols for new processes, equipment, and...
-
Validation Engineer
3 days ago
Singapore TRITON AI PTE. LTD. Full timeRoles & ResponsibilitiesIndustry: Pharma ManufacturingWork Location: TuasResponsibilities: Validation Activities: Assist in executing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and temperature mapping. Temperature Mapping: Conduct and document temperature mapping studies. Documentation: Maintain...
-
Validation Specialist
3 days ago
Singapore ALWAYSHIRED PTE. LTD. Full timeJob Title: Equipment Validation EngineerAt AlwaysHired Pte Ltd, we are seeking a highly skilled Equipment Validation Engineer to join our team. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our equipment and processes.Key Responsibilities:Perform risk-based commissioning, qualification, and validation...
-
Software Validation Engineer
3 days ago
Singapore STEERING HOLDING PTE. LTD. Full timeJob Title: Software Validation EngineerWe are seeking a highly skilled Software Validation Engineer to join our team at STEERING HOLDING PTE. LTD. in Suzhou, China. As a key member of our engineering team, you will be responsible for developing and executing test plans to validate complex embedded software features and communication protocols.Key...
-
Commissioning & Validation Engineer - LSMG
3 days ago
Singapore COGNIZANT TECHNOLOGY SOLUTIONS ASIA PACIFIC PTE. LTD. Full timeAbout the RoleCognizant Technology Solutions Asia Pacific Pte. Ltd. is seeking a highly skilled Commissioning & Validation Engineer to join our team. As a key member of our organization, you will be responsible for providing scientific and technical support for lab equipment validation and revalidation activities.Key ResponsibilitiesValidation and...
-
Validation Engineer
3 days ago
Singapore AMARIS CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesJob Description Validation Protocols: Develop, execute, and document validation protocols for equipment, processes, and systems in compliance with GMP regulations and industry standards. Documentation: Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs), ensuring...
-
QC Validation Engineer
3 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timeRoles & ResponsibilitiesPosition: QC Validation EngineerAt 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.Job Description:We are currently expanding our team and are...
-
Validation Specialist
3 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timeJob Title: Validation EngineerJoin our team at Coalesce Management Consulting PTE. Limited as a Validation Engineer and contribute to the success of our clients in the pharmaceutical and biotechnological industry.Job Summary:We are seeking a highly skilled Validation Engineer to join our team. As a Validation Engineer, you will be responsible for planning,...
-
QA Validation Engineer
3 days ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timeRoles & ResponsibilitiesPosition: QA Validation EngineerAt 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.Job Description:We are currently expanding our team and are...
-
Commissioning & Validation Engineer - LSMG
3 days ago
Singapore COGNIZANT TECHNOLOGY SOLUTIONS ASIA PACIFIC PTE. LTD. Full timeRoles & ResponsibilitiesCommissioning & Validation EngineerJob PurposeProvide scientific / technical support for lab equipment validation / revalidation and requalification activities including computerized systems performed in compliance to cGMPs, SOPs and applicable guidelines and normatives, with continuous improvement in quality and efficiency.Major...
-
CQV Engineer
3 days ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeAbout the RoleWe are seeking a highly skilled CQV Engineer to join our team at NUSANTARA PRIME CONSULTING PTE. LTD. as a key member of our Pharmaceutical Validation team.Key ResponsibilitiesEquipment Qualification: Develop, review, and approve validation lifecycle documents and protocols/reports, ensuring compliance with company policies, procedures, and...
-
Validation Specialist
3 days ago
Singapore ONE STOP ENGINEERING PTE. LTD. Full timeJob Title: Validation EngineerWe are seeking a highly skilled Validation Engineer to join our team at ONE STOP ENGINEERING PTE. LTD. The successful candidate will be responsible for providing expertise in EFU Validation activities, ensuring compliance with GMP regulations and industry practices.Key Responsibilities:Act as the Subject Matter Expert (SME) for...
-
Validation Engineer
4 months ago
Singapore MIKRON SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesMain Responsibilities:1. 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 – Quality, Cost, Time.3. Responsible to drive and support project team for projects where validation is required and...
-
Computer System Validation Engineer
3 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...