957 Validation Engineer jobs in Singapore

Position: Validation Engineer

We are Coalesce Management Consulting - 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 and are looking for a Validation Engineer to support projects on-site with a client.

Key Responsibilities:

• Prepare and execute validation protocols (URS, IOQ, PQ, FMEA, PVP) for equipment such as CIP tanks, robotic cleaners, and utility systems
• Conduct cleaning validation, temperature mapping, and requalification activities
• Ensure timely delivery of validation documentation and compliance with project timelines
• Develop and review qualification documentation (DQ, IQ, OQ, PQ, SAT, QSR) in both paper-based and digital platforms (KNEAT)
• Support validation of chemical production systems and cleanroom equipment
• Coordinate equipment change releases and ensure timely CR closures

Requirements:

• Degree related to Science or Engineering.
• Good knowledge and experience in GMP facilities.
• At least 5 years of experience in manufacturing, and biopharmaceutical industries.
• Ability to multitask and work in a fast-paced environment with competing priorities.
• Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels.
• Exhibit continuous improvement mindset and innovative thinking

What's in it for you?

• Greatest exposure to the Big Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

If you are interested in applying for this position, please send an email to

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.

We are seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer with over 8 years in the pharmaceutical and cGMP industry.

• Lead and participate in Engineering, Procurement, Construction, Validation for GMP facilities.
• Prepare, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
• Conduct root cause analysis and lead quality investigations (deviations, CAPA, change control).
• Manage validation schedules and resource alignment.
• Support manufacturing process setup and technical activities.
• Perform FAT/SAT activities and temperature mapping.
• Utilize Delta V, Kneat, Veeva, and Trackwise.

• 8+ years CQV experience in pharma/cGMP.
• Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.
• Proven problem-solving and project coordination skills.
• Excellent communication abilities.
• Bachelor of Science in Chemical/Biological Engineering or related field.

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.

• Provide quality oversight for validation, qualification, and equipment replacement projects within manufacturing environments
• Review and approve acceptance test protocols and reports in line with applicable procedures and standards
• Review and approve deviations, changes, and investigations related to validation and qualification activities
• Collaborate with cross-functional teams to organize, plan, and ensure efficient execution of qualification activities
• Lead and manage the product transfer process for new product introductions (NPI) and site-to-site technology transfers
• Support implementation of future connectivity and digital validation strategies
• Participate in continuous improvement of validation practices and documentation
• Ensure compliance with internal and regulatory requirements during validation processes

• Experience with process validation methodologies (IQ, OQ, PQ)
• Experience in New Product Introduction (NPI) and managing technology transfers across manufacturing sites
• Experience in equipment qualification and validation processes within pharmaceutical manufacturing
• Experience reviewing and approving documentation (IQ/OQ/PQ, protocols, reports), deviations, and change requests
• Knowledge of cGMP, GAMP, and relevant regulatory requirements
• Understanding of quality risk management principles and validation lifecycle
• Academic background: Bachelor's degree in Pharmaceutical Engineering, Life Sciences, or related field
• Experience with CIP/SIP, Autoclave, and buffer preparation processes
• You have excellent problem-solving and analytical skills, and an ability to work both independently and collaboratively with cross-functional teams

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.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Rachael Lee | EA Reg No.: R

We are seeking a highly skilled professional to support projects on site with clients, collaborating with cross-functional teams to define system requirements and develop robust validation plans.

• Develop and execute CSV strategies for DeltaV systems, ensuring alignment with regulatory requirements and project timelines.
• Conduct and oversee validation activities including IQ, OQ, and PQ to ensure systems meet compliance, performance, and reliability standards.
• Perform risk assessments and impact analyses to proactively identify potential gaps, and implement appropriate mitigation strategies.
• Prepare comprehensive validation documentation such as plans, protocols, reports, and SOPs.
• Provide leadership and hands-on support throughout system configuration, testing, and deviation management.

This role requires up-to-date knowledge of evolving regulatory requirements, industry standards, and innovations related to CSV and DeltaV technologies.

You will be part of a high-performing team delivering high-end projects for global businesses.

We operate as an equal opportunity employer, committed to diversity and inclusion.

We are seeking a highly skilled Validation Specialist to fill a key role in our organization.

• Collaborate with the Quality Manager to deliver tasks on time and to a high standard.
• Execute validation procedures for customer projects, ensuring quality, cost, and timeliness.
• Support project teams by driving validation efforts, ensuring alignment with organizational standards.
• Provide training on qualification activities and ensure documentation meets required standards.
• Maintain documentation standards and procedures for qualification activities.
• Create and maintain qualification/validation documents from design phase for mechanical, software, and hardware components.
• Lead qualification/validation activities of projects (risk analysis, protocol development, and test execution) internally and at partners' sites.

• Degree in Mechanical Engineering or equivalent qualification.
• Minimum 2 years of 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, testing, and debugging procedures.

Responsibilities:

• Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
• As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
• Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert
• Generate, review and execute protocols/test cases for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification.
• Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
• Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope in a Biologics manufacturing facility.
• Any other tasks assigned by Line Manager.

About You:

• Minimum bachelor's degree or higher in Science or Engineering or equivalent with at least 3 years of relevant work experience
• Minimum 1 year experience with Emerson DeltaV system – software coding review.
• Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus
• Hands-on experience in Validation life cycle of computer systems is a must.
• Experience in Siemens PLC system is a plus
• Good communication skills
• Excellent team player willing to work for the common goal
• Knowledge of pharmaceutical regulatory requirements (GMP) is essential
• Shows a high level of tenacity to ensure closure of issues.
• Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met.