702 Process Validation jobs in Singapore

We are looking for a Validation Engineer to support a range of qualification and validation activities across critical equipment and controlled environments. This role involves the execution of temperature mapping, equipment validation, protocol development, and performance verification to ensure compliance with regulatory standards and internal quality systems.

Key Responsibilities:

• Temperature Mapping & Environmental Qualification:
• Conduct thermal mapping studies for Cold Rooms (2°C to 8°C), Freezers, and Incubators using Kaye AVS (Advanced Validation System).
• Prepare and execute IOPQ protocols, perform data analysis, and compile comprehensive validation summary reports.

Autoclave Validation:

• Manage requalification of site autoclaves and qualification of new units, ensuring alignment with cGMP standards.
• Support introduction of new loads such as towel packs and perform specialized tests like the Air Detector Test.
• Develop and execute SOPs, OPQ protocols, and performance verification plans for all validated loads.

Equipment Validation:

• Validate and qualify Kaye Validator AVS systems through IOQ protocol development, execution, and reporting.
• Support calibration and maintenance of validation instrumentation and document performance accordingly.

Airflow Visualization Studies:

• Perform smoke studies (air visualization) for biosafety cabinets (BSCs), cleanroom zones, and equipment doors in compliance with cleanroom standards.
• Execute protocols and prepare clear and accurate documentation including study reports.

Documentation & Compliance:

• Draft validation documentation including protocols, deviation reports, and final summary reports.
• Identify and resolve discrepancies in validation findings, escalating issues as needed.
• Prepare and maintain validation maintenance reports for facility and equipment (F&E).

Requirements:

• Bachelor's Degree or Diploma in Engineering, Life Sciences, or a related technical discipline.
• Solid experience in equipment qualification, environmental validation, and temperature mapping using Kaye AVS.
• Knowledge of regulatory standards including cGMP, GDP, and GxP.
• Strong understanding of validation lifecycle: IQ, OQ, PQ, and requalification.
• Excellent technical writing, data analysis, and problem-solving skills.
• Ability to work independently and collaboratively across functional teams.

Preferred Qualifications:

• Previous experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Familiarity with cleanroom validation and environmental monitoring standards.

This role is responsible for supporting validation activities including develop, support and implementation. In this role, the engineer must ensure qualification activities are performed in accordance with the company's policies and procedures, and regulatory requirements.

Responsibilities:

• Support equipment, facilities, utilities qualifications
• Develop validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and complete execution in a timely fashion,
• Manage qualification execution and lead qualification deviation investigations encountered during qualification
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
• Participate in site Validation Maintenance Program
• Support Change Implementation on site
• Any other tasks as and when assigned by supervisor / Manager
• Support other technical changes and duties as required

About You:

• Engineering/Science Degree or higher from recognised institution
• At least 2 years of experience in Equipment Qualification in the pharmaceutical/biotech industry.
• Experience in Critical Utilities, process equipment and facilities qualification is preferred.
• Must have experience in controlled temperature chamber qualification with temperature mapping.
• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
• Good Knowledge of Upstream, Downstream and Support Services equipment within the Pharma Biotech Industry.
• Good oral and written communication skills.
• Meticulous and Systematic
• Team player, with strong focus on safety, quality and timeline
• GMP/cGMP knowledge a plus
• Self-motivated and capable of working in diverse team situations with company clients and maintaining a positive attitude towards project challenges.

Duration : 09 months. Option to extend/convert subject to performance review.

Based in Tuas.

Rapsodo is a Sports Technology company with offices in the USA, Singapore, Turkey & Japan. We develop sports analytics products that are data-driven, portable and easy-to-use to empower athletes at all skill levels to analyse and improve their performance. From Major League Baseball star pitchers to Golf tour players, athletes use Rapsodo technology to up their game across the world. Trusted by coaches and players from youths to professionals, Rapsodo provides real-time insights for all-time performance. We are innovative, focused, and rapidly growing. We are continuously looking for team players who will stop at nothing to deliver state-of-the-art solutions as part of Team Rapsodo.As a Hardware Validation Engineer, you will play a critical role in ensuring the quality and reliability of our hardware products through comprehensive testing and validation processes. You will collaborate closely with cross-functional teams, including hardware design, software development, and manufacturing, to deliver high-performance and robust solutions.

Responsibilities

• Develop and execute hardware validation plans, test cases, and procedures to ensure compliance with design specifications and industry standards
• Design and implement test setups, test equipment, and automation frameworks for efficient and accurate validation testing
• Perform functional and performance testing of hardware components, systems, and subsystems, including but not limited to PCBs, integrated circuits, connectors, and power system
• Conduct thorough analysis and troubleshooting of hardware issues, identifying root causes and proposing effective solution
• Collaborate with design engineers to provide design feedback and recommendations for improvements based on validation findings
• Participate in design reviews and provide input on design aspects from a validation perspective
• Generate detailed test reports and documentation to communicate validation results and findings to relevant stakeholders
• Stay up-to-date with industry trends, emerging technologies, and best practices related to hardware validation methodologies and tools
  
  

Requirements

• Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or a related field
• 2 – 5 years of proven experience as a Hardware Validation Engineer in the consumer electronics industry or a similar role
• Strong knowledge of hardware testing methodologies, tools, and equipment
• Proficiency in programming languages such as C/C++, Python, or LabVIEW for test automation
• Proven experience with lab equipment, such as oscilloscopes, logic analysers, spectrum analysers, and signal generators
• Familiarity with industry standards and protocols, such as MIPI CSI-2, USB, HDMI, LVDS, Ethernet
• Knowledge of compliance testing and certification processes, such as FCC, CE
• Solid understanding of digital and analog circuitry, signal integrity, and power delivery
• Excellent problem-solving skills and the ability to analyse and debug complex hardware issues
• Strong communication and teamwork skills to collaborate effectively with cross-functional and cross-cultural teams
• Attention to detail and a commitment to delivering high-quality results
• Familiarity with scripting languages, such as Perl or Bash
  
  

Rapsodo is a Sports Technology company with offices in the USA, Singapore, Turkey & Japan. We develop sports analytics products that are data-driven, portable and easy-to-use to empower athletes at all skill levels to analyse and improve their performance. From Major League Baseball star pitchers to Golf tour players, athletes use Rapsodo technology to up their game across the world. Trusted by coaches and players from youths to professionals, Rapsodo provides real-time insights for all-time performance. We are innovative, focused, and rapidly growing. We are continuously looking for team players who will stop at nothing to deliver state-of-the-art solutions as part of Team Rapsodo.As a Hardware Validation Engineer, you will play a critical role in ensuring the quality and reliability of our hardware products through comprehensive testing and validation processes. You will collaborate closely with cross-functional teams, including hardware design, software development, and manufacturing, to deliver high-performance and robust solutions.

Responsibilities

• Develop and execute hardware validation plans, test cases, and procedures to ensure compliance with design specifications and industry standards
• Design and implement test setups, test equipment, and automation frameworks for efficient and accurate validation testing
• Perform functional and performance testing of hardware components, systems, and subsystems, including but not limited to PCBs, integrated circuits, connectors, and power system
• Conduct thorough analysis and troubleshooting of hardware issues, identifying root causes and proposing effective solution
• Collaborate with design engineers to provide design feedback and recommendations for improvements based on validation findings
• Participate in design reviews and provide input on design aspects from a validation perspective
• Generate detailed test reports and documentation to communicate validation results and findings to relevant stakeholders
• Stay up-to-date with industry trends, emerging technologies, and best practices related to hardware validation methodologies and tools
  

Requirements

• Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or a related field
• 2 – 5 years of proven experience as a Hardware Validation Engineer in the consumer electronics industry or a similar role
• Strong knowledge of hardware testing methodologies, tools, and equipment
• Proficiency in programming languages such as C/C++, Python, or LabVIEW for test automation
• Proven experience with lab equipment, such as oscilloscopes, logic analysers, spectrum analysers, and signal generators
• Familiarity with industry standards and protocols, such as MIPI CSI-2, USB, HDMI, LVDS, Ethernet
• Knowledge of compliance testing and certification processes, such as FCC, CE
• Solid understanding of digital and analog circuitry, signal integrity, and power delivery
• Excellent problem-solving skills and the ability to analyse and debug complex hardware issues
• Strong communication and teamwork skills to collaborate effectively with cross-functional and cross-cultural teams
• Attention to detail and a commitment to delivering high-quality results
• Familiarity with scripting languages, such as Perl or Bash
  

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

Position Overview

We are looking for a Validation Engineer to manage and execute validation activities, including equipment, utilities, and facility qualifications. You will develop and support the creation of validation documentation, apply a science-based approach to validation, analyze data, and assist with investigating deviations. Collaboration with cross-functional teams and adherence to safety, quality, and regulatory standards are key aspects of this role to ensure the successful delivery of validation projects.

Key Responsibilities

• Develop, execute, and document protocols (IQ, OQ, PQ) and reports for new qualification.
• Coordinate the completion of cleaning performance qualification.
• Investigate and resolve discrepancies/incidents arising from qualification activities.
• Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
• Support change control activities, ensuring proper validation assessments and documentation.
• Support other day-to-day validation activities, ensuring adherence to approved Validation SOPs, Plans, and Policies.
• Work closely with End-Users, Quality, and Engineering functions to ensure validation activities are completed as planned.

Required Qualifications

• Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility.
• Relevant experience in validation of facility, equipment, utility, cleaning, and/or sterilization.
• Familiarity with Regulatory requirements and Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
• Ability to read and interpret technical documentation, system specifications, and validation protocols.
• Strong analytical, problem-solving, and organizational skills.
• Excellent communication skills and ability to work in a team-oriented environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Willingness to learn and adapt in a fast-paced, regulated industry.

Why join us?

• Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

We are looking for a Validation Engineer to support a range of qualification and validation activities across critical equipment and controlled environments. This role involves the execution of temperature mapping, equipment validation, protocol development, and performance verification to ensure compliance with regulatory standards and internal quality systems.

Key Responsibilities:

• Temperature Mapping & Environmental Qualification:
• Conduct thermal mapping studies for Cold Rooms (2°C to 8°C), Freezers, and Incubators using Kaye AVS (Advanced Validation System).
• Prepare and execute IOPQ protocols, perform data analysis, and compile comprehensive validation summary reports.

Autoclave Validation:

• Manage requalification of site autoclaves and qualification of new units, ensuring alignment with cGMP standards.
• Support introduction of new loads such as towel packs and perform specialized tests like the Air Detector Test.
• Develop and execute SOPs, OPQ protocols, and performance verification plans for all validated loads.

Equipment Validation:

• Validate and qualify Kaye Validator AVS systems through IOQ protocol development, execution, and reporting.
• Support calibration and maintenance of validation instrumentation and document performance accordingly.

Airflow Visualization Studies:

• Perform smoke studies (air visualization) for biosafety cabinets (BSCs), cleanroom zones, and equipment doors in compliance with cleanroom standards.
• Execute protocols and prepare clear and accurate documentation including study reports.

Documentation & Compliance:

• Draft validation documentation including protocols, deviation reports, and final summary reports.
• Identify and resolve discrepancies in validation findings, escalating issues as needed.
• Prepare and maintain validation maintenance reports for facility and equipment (F&E).

Requirements:

• Bachelor’s Degree or Diploma in Engineering, Life Sciences, or a related technical discipline.
• Solid experience in equipment qualification, environmental validation, and temperature mapping using Kaye AVS.
• Knowledge of regulatory standards including cGMP, GDP, and GxP.
• Strong understanding of validation lifecycle: IQ, OQ, PQ, and requalification.
• Excellent technical writing, data analysis, and problem-solving skills.
• Ability to work independently and collaboratively across functional teams.

Preferred Qualifications:

• Previous experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Familiarity with cleanroom validation and environmental monitoring standards.

Job Title: System Validation Specialist

We are seeking a skilled System Validation Specialist to join our team. As a key member of our Life Sciences Division, you will be responsible for ensuring the accuracy and reliability of our systems.

The successful candidate will have experience in designing, developing, and executing system validation strategies, as well as collaborating with cross-functional teams to define system requirements and develop robust validation plans.

You will conduct and oversee validation activities, including IQ, OQ, and PQ, to ensure systems meet compliance, performance, and reliability standards. Additionally, you will perform risk assessments and impact analyses to proactively identify potential gaps and implement appropriate mitigation strategies.

Responsibilities:

• Design and execute system validation strategies
• Collaborate with cross-functional teams to define system requirements
• Conduct and oversee validation activities
• Perform risk assessments and impact analyses

• Bachelor's degree in a related field (e.g., engineering, computer science)

• 5+ years of experience in system validation or a related field

• Excellent communication and collaboration skills

• Strong analytical and problem-solving skills

• Competitive salary and benefits package

• Opportunity for professional growth and development

• Collaborative and dynamic work environment What We Offer

We offer a comprehensive compensation package, including a competitive salary, medical coverage, annual leave options, and training and development allowance. You will also have the opportunity to work with world-class teams on high-end projects for global businesses.

Coalesce Management Consulting operates as an equal opportunity employer and welcomes applications from individuals of any background.

• Assist in the qualification / validation of new equipment / replacement of equipment project.
• Collaborate with multi functions to arrange, plan and ensure smooth running of the execution activities.
• Draft qualification / validation protocols / reports, execute qualification / validation of equipment in accordance with relevant policies, standards, procedures and guidelines timely
• Ensuring the implementation of safety policies during all site activities including pre-planning, review of safe work plans, preparation of site work documentation and monitoring of safe work methods during execution;
• Draft and manage qualification / validation exceptions, deviation and/or investigations encountered during acceptance test execution representing as Qualification / Validation SME.
• Support other technical changes and duties as required.

• Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry).
  •
• Min. 5 years of relevant working experience in GMP environments is preferred.
• Excellent communication skills, both written and verbal, in English.
• Ability to multitask and work in a fast paced environment with competing priorities.
• Great team player. Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels

• Exposure to the major Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

Job Description

• Industry/ Organization Type: Manufacturing
• Position Title: Validation Engineer
• Working Location: Tai Seng
• Working Hours: 5 days (Monday to Friday, 8.30 AM – 6 PM)
• Salary Package: Basic Salary up to $6,000 + AWS + Performance Bonus
• Duration: Permanent

Key Responsibilities

• Assist Quality and Validation Manager Asia to complete the tasks on time with good quality.
• Responsible for the successful execution of the Validation functions for customer projects, as required – Quality, Cost, and Time.
• Responsible for driving and supporting the project team for projects where validation is required and ensuring execution complies with company's standards.
• Provide training on qualification activities.
• Responsible for maintaining qualification documentation standards and procedures.
• Create and maintain qualification/validation documentation from the design phase of projects for mechanical, software, and hardware parts.
• Lead the qualification/validation activities of projects (risk analysis, protocol drafting, and test execution during FAT/SAT) internally and at our partners' sites (approximately 20% of the time on travel throughout the year).
• Any other ad-hoc duties as assigned.

APPLY NOW

• Diploma/Degree in Mechanical Engineering or equivalent
• Has 2 years of working experience in quality or validation of automated systems (mechanical, software, hardware) or equivalent
• Prior work experience in control systems design is advantageous
• Excellent understanding of assembly, test & debug procedures

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Please indicate #69403 on the email subject.

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