1,334 Validation Specialist jobs in Singapore

Job Opportunity

The company specializes in contract research and development of scientifically-driven products at competitive prices.

Our scientific focus is on emerging biology, utilizing cells to derive products or using them as factories to create target products.

We were the first to achieve a breakthrough success by being certified for cultivated/cell-based meat production under FSSC 22000 and recognized by a food regulatory body.

Operating an integrated facility for cell line creation, process development, analytical services, and fill & finish for cell therapy products places us at the forefront of our industry.

The Role

You will join our team responsible for Commissioning Qualification and Validation (CQV) activities and contribute to the overall site mission and objectives. Your primary task will be to ensure CQV activities are planned and executed efficiently while adhering to GxP standards.

Responsibilities

• Perform risk-based commissioning, qualification, and validation of pharmaceutical equipment, utilities, facilities, and processes.
• Develop validation protocols and reports that meet regulatory requirements and industry best practices.
• Collaborate in developing User Requirements Specification documents.
• Prepare design review and qualification documents at the initial design stage to align with specifications.
• Generate protocols and execute field work related to Installation & Operational Qualification (IOQ).
• Prepare and execute FMEA and validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation, and Transport Qualification as required.

Requirements

To excel in this role, you should have:

• A degree or diploma in Engineering/Science or related studies.
• A minimum of 1-3 years' experience in pharmaceutical/biopharmaceutical manufacturing.
• Familiarity with working in a GxP environment and the ability to adapt to new regulatory requirements and technologies.

Job Overview:

We are a contract research development and manufacturing organization founded by scientists who enable fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work focuses on emerging and frontier biology, utilizing cells as a final product or deriving products from cells which often we use cells as the factory to derive our target product.

We have achieved a remarkable commercial breakthrough success by being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We operate an end-to-end integrated full cell line creation/immortalization or engineered cell line, cell culture process development, analytical development for stem cells and exosomes with full cGMP Capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product.

Key Responsibilities:

• Ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner.
• Adhere to GxP standards while performing CQV activities.

Work Environment:

Your primary work location will be in Singapore.

The role involves working in a dynamic environment where you will contribute to the overall site mission and objectives.

Responsibilities:

• Validation quality review of lifecyle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification.
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 9 months

A key member of our Test and Quality Assurance team, you will lead a group of Associate Engineers/Technicians in delivering comprehensive testing services for Server & Rack products.

Job Title: Senior Component Validation Expert

As a Senior Component Validation Expert, you will be part of a forward-thinking team that solves complex problems. You will be responsible for enabling Micron's products with flawless and issue-free release to both internal and external customers.

Key Responsibilities:

• Coordinate with Internal and External Teams on Preparation for Silicon
• Work with Manufacturing teams to ensure resources are available
• Identify HBM Component Validation equipment needs
• Identify and validate HBM Component Validation equipment and testing flow

Ensure that Silicon Meets Product Expectations

• Debug and identify root cause for failures
• Implement fixes for fails (Design or Process)
• Work with Design Validation (DV) and Quality Assurance (QA) Teams on customer returns to identify new tests
• Work with Global Quality Team to ensure reliability

Partner with Engineering, Manufacturing and Marketing

• Create and deliver presentations both inside and outside Micron
• Participate in meetings
• Troubleshoot, develop or validate HBM Component Validation testing programs
• Evaluate data sheets and provide feedback to Application Engineers
• Prioritize work with other groups

Provide Technical Training and Expertise

• Provide On-the-Job Training (OJT) for new engineers
• Instruct on data presentation and techniques
• Assist with data interpretation
• Act as product-specific point of contact
• Attend technical seminars

• Bachelor's Degree or Master's Degree in related Engineering and a minimum 4 years experience, preferably in Memory semiconductor industry, with a balance of both hardware and software skill sets
• Proven experience working and programming with Linux, Python/C/C++, Verilog, UVM, version control systems (git, svn)
• Excellent problem-solving and analytical skills
• Works well in a team environment
• Good communication, data analytics and presentation skills
• Basic understanding of HBM and/or DRAM operations and computer networking
• Self-motivation and passion

• Comfortable working with lab equipment including oscilloscopes and logic analyzers
• Previous experience validating products with both hardware/firmware/software components

Get AI-powered advice on this job and more exclusive features.
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries?
PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.
Due to our constant growth, we are looking for a
Validation QA
to support our projects in Singapore.
You will be responsible for:
Overseeing routine quality control activities for on-site GMP production and testing, ensuring strict adherence to company procedures and regulatory requirements.
Providing quality oversight for validation and re-qualification activities, maintaining validation status at all times.
Reviewing and approving all Qualification and Validation protocols and reports, including those for QC instruments, facilities, utilities systems, and computer systems.
Ensuring data integrity and compliance of all documentation and electronic data with applicable regulations and SOPs.
Supporting the establishment and maintenance of an effective Quality System across all GMP processes.
Participating in site operational readiness programs, including self-inspections and data integrity surveillance for GMP and client audits.
Managing quality events such as deviations, change controls, CAPAs, and laboratory investigations.
Performing additional QA tasks as assigned by leadership.
About you:
Bachelor’s degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or a related field.
3–5 years of relevant QA experience in the biopharma or pharmaceutical industry.
Strong knowledge of FDA, EMA, and PIC/S GMP requirements.
Familiarity with biological product manufacturing and related quality control processes.
Previous experience with biopharma commercial supply is preferred.
Experience in new site start-up activities is a plus.
Strong proficiency in English (listening, speaking, reading, writing).
Skilled in Microsoft Word, Excel, and PowerPoint.
Excellent cross-functional communication and collaboration skills.
Strong logical thinking, ownership, and conflict management abilities.
First Project you will be assigned to:
Availability : Full on-site
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation . PQE Group gives you the
opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.
If you are looking for a
rewarding and exciting career , PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Full-time
Job function
Job function Quality Assurance and Manufacturing
Industries Business Consulting and Services and IT Services and IT Consulting
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Responsibilities:

• Validation quality review of lifecyle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification.
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 9 months

We are seeking a Senior Component Validation Engineer to join our Heterogenous Integration team. In this role, you will be part of a forward-thinking group of engineers that solves complex problems.

• Coordinate with internal and external teams on silicon preparation.
• Work with manufacturing teams to ensure resources are available.
• Identify HBM component validation equipment needs.
• Validate HBM component validation equipment and testing flow.

• Ensure silicon meets product expectations.
• Debug and identify root cause for failures.
• Implement fixes for fails (design or process).
• Work with design validation and quality assurance teams on customer returns.

• Create and deliver presentations both inside and outside the company.
• Participate in meetings.
• Troubleshoot, develop or validate HBM component validation testing programs.
• Evaluate data sheets and provide feedback to application engineers.

• Bachelor's degree or master's degree in related engineering with at least 4 years experience.
• Proven experience working and programming with Linux, Python/C/C++, Verilog, UVM, version control systems (git, svn).
• Excellent problem-solving and analytical skills.
• Works well in a team environment.
• Good communication, data analytics and presentation skills.

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• Oversee the implementation and maintenance of GMP and HACCP standards.
• Ensure compliance with local food regulations (e.g., SFA and GMP standards).
• Manage internal and external audits (e.g., regulatory bodies, customer audits).
• Review and update QA documentation, SOPs, and records regularly.
• Food Safety & Risk Management
• Lead hazard analysis, food safety plans, and critical control point monitoring.
• Manage allergen control, traceability, and recall procedures.
• Quality Control Oversight
• Supervise the QC team in performing inspections, sampling, and laboratory testing (microbiological, chemical, physical).
• Analyze trends from quality data and implement improvements.
• Approve incoming raw materials, in-process, and finished product quality.
• Train and mentor junior QA/QC staff on quality systems and food safety.
• Conduct regular staff training on hygiene, GMP, and process controls.
• Initiate and lead quality improvement projects (e.g., reducing customer complaints, process optimization).
  
  

• Quality Assurance & Compliance
• Oversee the implementation and maintenance of GMP and HACCP standards.
• Ensure compliance with local food regulations (e.g., SFA and GMP standards).
• Manage internal and external audits (e.g., regulatory bodies, customer audits).
• Review and update QA documentation, SOPs, and records regularly.
• Food Safety & Risk Management
• Lead hazard analysis, food safety plans, and critical control point monitoring.
• Manage allergen control, traceability, and recall procedures.
• Quality Control Oversight
• Supervise the QC team in performing inspections, sampling, and laboratory testing (microbiological, chemical, physical).
• Analyze trends from quality data and implement improvements.
• Approve incoming raw materials, in-process, and finished product quality.
• Team Leadership & Training
• Train and mentor junior QA/QC staff on quality systems and food safety.
• Conduct regular staff training on hygiene, GMP, and process controls.
• Continuous Improvement
• Initiate and lead quality improvement projects (e.g., reducing customer complaints, process optimization).
  
  

• Degree/Diploma in Food Science, Food Technology, Microbiology, or related field.
• 5 years of QA/QC experience in the food manufacturing industry.
• Strong knowledge of HACCP and GMP standards.
• Experience with audits, documentation control, and risk assessment.
• Excellent communication, leadership, and problem-solving skills.

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Quality Assurance
• Industries Pharmaceutical Manufacturing

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Queenstown, Central Singapore Community Development Council, Singapore 1 day ago

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